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37 Study Matches

Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

Ian Ramsay
All
18 Years to 64 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02085421
1311M45305
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Inclusion Criteria:

• Meet diagnostic criteria for schizophrenia or schizoaffective disorder
• Are age 18-64
• Fluent in written and spoken English
• Have an outpatient status of at least 1 month prior to participation
• Has been on a stable dose of psychiatric medication for at least one month prior to participation
Exclusion Criteria:

• History of seizures or epilepsy
• Metallic cranial plates, screws, or implanted devices
• History of craniotomy
• History of stroke
• History of eczema on scalp
• Pre-existing sores or lesions at sites of tDCS electrode placement
• Non removable facial piercings
• Current or possibility of current pregnancy
• Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months
Device: tDCS
Psychosis
tdcs, neuromodulation, CRT, psychosis, schizophrenia
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Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®

All
12 Years to 17 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT01908192
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Inclusion Criteria:

• Male or female subjects who are between 12 and 17 years of age inclusive
• Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0)
• Are clinically stable with residual symptoms, defined as a total score of ≥ 60 of PANSS and a score of ≥ 40 for SANS
• An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to randomization into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole (Maintena®) and Paliperidone (Xeplion®); six (6) months for Olanzapine pamoate monohydrate (Zypadhera®); and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)
• In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) are clinically unremarkable per the investigator
• Subject has a negative urine illicit drug screening test
• Subject understands and is willing to sign the Informed Assent Form (IAF) prior to study entry and agrees to be available for all the study visits
• The subject's guardian understands and is willing to sign the Informed Consent Form (ICF) prior to study entry and agrees to be available for all the study visits
• Must not be a danger to self or others and must have family support available to be maintained as outpatients
Exclusion Criteria:

• Meets the DSM-IV or -V criteria at screening for mental retardation, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders; e.g., attention-deficit hyperactivity disorder (ADHD), are allowed as long as schizophrenia is the primary diagnosis and the comorbid disorder(s) do not require medication.
• Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose
• History of epilepsy, head trauma, or neurological illness other than Tourette's syndrome
• History of allergic reaction to sodium benzoate
• Serious medical illnesses such as acute or chronic renal disease, liver failure or heart disease that, in the opinion of the investigator, may interfere with the conduct of the study.
• Current substance abuse or positive urine illicit drug screening or history of substance dependence (including alcohol, but excluding nicotine and caffeine) in the past three (3) months.
• Use of depot antipsychotics in the past six (6) months
• Inability to follow protocol
• Body Mass Index (BMI) > 35
• Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are nursing, or who do not agree to abstinence or birth control during the study
• Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
• Previous participation in an intervention trial within 30 days of randomization
• Subjects whose PANSS score has decreased more than 10 percent during the Screening Phase
Drug: NaBen®, Drug: Placebo
Schizophrenia
Sodium Benzoate, Schizophrenia, Adolescent, Antipsychotic, Anti-psychotic, NMDA, NaBen, pediatric
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Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation

The primary objective of the study is to assess the efficacy of patient controlled sedation (Self-management of sedative therapy) using dexmedetomidine to reduce anxiety, delirium incidence and duration of mechanical ventilation compared to usual sedation practices in mechanically ventilated subjects.

Craig Weinert
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02819141
1605M88241
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Inclusion Criteria:

• Subject is acutely mechanically ventilated during the current hospitalization.
• Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
• Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
• Subject Age ≥ 18 years
• Subject or their proxy is capable of providing informed consent
Exclusion Criteria:

• Aggressive ventilatory support or prone ventilation.
• Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded.
• Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
• Paralysis or other condition preventing the use of push button device
• Positive pregnancy test or lactation
• Acute hepatitis or liver failure (direct bilirubin >5 mg/dL)
• Acute stroke or uncontrolled seizures.
• Acute myocardial infarction within 48 hours prior to enrollment.
• Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)
• Assessed RASS -3, -4, -5 or RASS +2,+3, +4
• Chronic ventilator support in place of residence prior to current hospitalization.
• Imminent extubation from mechanical ventilator support.
Drug: Dexmedetomidine
Critical Illness, Anxiety, Respiratory Failure
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Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program (ADS Plus)

To evaluate the efficacy of ADS Plus, a family-based intervention program, in 30 adult day service programs throughout the United States among 240 family caregivers over a 12-month evaluation period.

All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02927821
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Inclusion Criteria:
Caregivers are eligible to participate at time of intake at an Adult Day Service (ADS) if they:
• are initially enrolling their relative in one of the 30 participating ADS sites
• expect to use ADS for a minimum of 1 week for 6 months
• have primary responsibility for care of the ADS client
• speak English
• provided > 8 hours of assistance to client in past week
• have a telephone and are willing to participate in 4 telephone interviews (baseline, 3 month check-in; 6 and 12 month follow-ups)
• are 21 years of age or older (male or female).
Exclusion Criteria:
caregivers and older adult clients are not eligible if:
• they plan to move from the area within 6 months
• either caregiver or client has been hospitalized >3 times in past year
• either caregiver or client is in active treatment for a terminal illness or are in hospice
• caregiver is involved in other caregiver support services/trials.
Behavioral: ADS Plus
Stress
Adult Day Care Centers, Caregivers
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Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa

Ann Haynos
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT03275545
STUDY00000818
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Inclusion Criteria:

• Age > 18 years old
• Current BMI > 18.5 kg/m2
• Ability to read and speak in English
• Right-handed
• Weight restored Anorexia Nervosa group: 1) DSM-5 diagnosis of AN in the past 6 months, with the exception of body image disturbance and intense fear of weight gain criteria; 2) BMI < 18.5 kg/m2 within past 6 months
Exclusion Criteria:

• Medical instability or current pregnancy
• Current substance use disorder, psychosis, or bipolar-I disorder
• Contraindication for fMRI
• History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
• Food allergy that cannot be accommodated through substitutions to the laboratory test meal
• Lacking capacity to consent
• Non-eating disorder Control group: Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
Other: No intervention
Anorexia Nervosa
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Psychophysiological Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorders: Diagnosis and Alcohol Use Outcomes

Comorbid AUD+AnxD is a significant barrier to successful AUD treatment. Converging evidence implicates overlap in dysregulation of systems governing stress response (HPA, ANS, CNS) for symptom development in AUD and AnxD. However, this must be systematically demonstrated in comorbid AUD+AnxD. We will assess markers of multi-system biological stress regulation (at rest and in response to laboratory challenge) in alcohol use disorder (AUD) inpatients with and without co-occurring anxiety disorder (AnxD), as well as those with AnxD who do versus do not receive a cognitive behavioral treatment that specifically targets comorbid AUD-AnxD. Laboratory measures include 1) cortisol (to assess the hypothalamic–pituitary–adrenal axis system [HPA] function; 2) heart rate variability (to assess autonomic nervous system [ANS] function), and 3) threat-potentiated startle (to assess central nervous system [CNS] function). Laboratory assessments will occur at the following times: 1) shortly after AUD treatment admittance (Visit 2: Pre-Treatment), 2) immediately following the 4-week AUD treatment (Visit 3: Post-Treatment), 3) 1 month following AUD treatment (Visit 4: 1-Month Follow-Up), and 4) 4 months following AUD treatment (Visit 5: 4-Month Follow-Up). Self-reported alcohol intake will be assessed at baseline as well as at the 1- and 4-Month Follow-Ups to determine whether laboratory stress measures predict treatment outcomes. A single laboratory assessment of healthy controls will serve as a normative reference for characterizing patient laboratory responses in terms of dysregulation and re-regulation.

Justin Anker
All
18 Years to 65 Years old
NA
This study is also accepting healthy volunteers
NCT03056872
1612M02641
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Inclusion Criteria:

• Ability to provide informed consent
• Between the ages of 18 and 65
• Diagnostic and Statistical Manual diagnosis of a Panic Disorder, Generalized Anxiety Disorder, or Social Anxiety Disorder within the past 30 days (AUD+AnxD group only).
• Primary alcohol use disorder diagnosis and alcohol use in the 30 days preceding the study (AUD alone and AUD+AnxD groups only).
• Inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug with nicotine accepted) dependence (AUD alone and AUD+AnxD groups only).
• A minimum of a sixth-grade reading level.
• Healthy controls, same criteria absent AUD and AnxD diagnosis of an alcohol and/or anxiety disorder
• Lives within proximity to the Twin Cities (e.g., within about an hour's drive) or willing to drive to Fairview for the purpose of attending follow-up visits
• Willingness to provide contact information to confirm follow-up appointments
Exclusion Criteria:

• Lifetime history of psychosis or mania
• Cognitive impairment, physical impairment, or chronic medical illness that precludes study participation
• Primary PTSD as determined by qualifying assessment
• Females currently pregnant
• Exposure to antipsychotic medication for a total duration >16 weeks.
• Prior head injury leading to >30 minutes of unconsciousness.
• Cognitive impairment that impedes study participation.
• Healthy controls with a history of any major medical or psychiatric disorders (e.g., schizophrenia, depression, heart disease, or stroke).
• Suicide intent or attempt in the past 30 days
• Cardiovascular health issues
• Thyroid Disease
• History of severe neurological illness such as chronic seizure disorder (e.g, epilepsy) or stroke
• Brain tumor and/or implants in the skull cavity (e.g., plate in the skull)
• Pacemaker
Alcohol Use Disorder, Anxiety Disorder/Anxiety State, Stress Disorder, Hypothalamic Pituitary Adrenal, Drinking to Cope
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Neuromodulation and Cognitive Training in Opioid Use Disorder

Patients will receive 20 minutes of continuous stimulation of either active or sham transcranial direct current stimulation every day for five consecutive days. This will allow investigation to whether the pairing of dorsolateral prefrontal corex stimulation and cognitive flexibility training can enhance functional connectivity between dorsolateral prefrontal corex and nucleaus accumbens, assisting with treatment for opioid use disorder.

Jazmin Camchong
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03773523
STUDY00005047
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Inclusion Criteria:

• 20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
• This 28-day program provides a supervised environment to treat individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid use disorder.
• Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
• A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
• Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
• DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
• Presence of a condition that would render study measures difficult or impossible to administer or interpret
• Age outside the range of 18 to 60
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Clinical evidence for Wernicke-Korsakoff syndrome
• Nicotine use will be recorded.
Device: Transcranial Direct Current Stimulation (tDCS)
Opioid-use Disorder, Opioid Dependence, Opioid Abuse
tDCS, Transcranial Direct Current Stimulation, MRI, Opioid dependence, Opioids, Buprenorphine, Suboxone, Lodging Plus, Fairview Lodging Plus
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A closed-loop assessment and treatment platform for unipolar depression and anxiety

This study is a validation study to evaluate the acceptability and feasibility of the closed-loop strategy employing the mobile mental health application with the target population to prepare for a large-scale efficacy trial in adults with MDD, depression and/or anxiety.

Gamze Camsari
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02948036
STUDY00004179
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Inclusion Criteria:

• Participant must be 18 to 60 years of age.
• Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9).
• Participant taking antidepressants or engaged in psychotherapy will not be excluded. If potential participants are currently prescribed psychotropic medication, they must be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based on self-report or as verified by medical health records, when available and authorized.
• Participant must be a fluent English speaker.
• Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer as required to complete study activities.
• Participant must have access to wireless Internet connectivity.
• Participant must be willing to communicate with study staff via email.
Exclusion Criteria:

• Participant with unstable and/or untreated conditions that may affect cognition, including untreated substance abuse/dependence disorders, unmanaged cardiovascular disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g., radiation) .
• Participant with history or current DSM-5 diagnosis of psychosis, such as schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders.
• Participant has a history or current diagnosis of dementia and/or scores less than a 14 (75%) on the UBACC.
• Participant with active suicidal ideations or behaviors within 2 months of screening.
• Participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the Principal Investigators.
• Participant has problems performing assessments or comprehending or following spoken instructions, or those with behaviors during screening or baseline visits that, in the judgment of the screening staff, are likely to present significant problems for the staff conducting assessments.
• Participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable..
• Participant is using computer-based cognitive training programs or has used it within a month of the consent date.
Other: Mobile-device, plasticity-based adaptive cognitive treatment
Major Depressive Disorder
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Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 (MINUTES)

All
18 Years to 60 Years old
N/A
This study is also accepting healthy volunteers
NCT03896425
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Inclusion Criteria:

• Ability to provide consent and comply with study procedures.
• Age 18 - 60 years old.
• Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
• No Serious and Persistent Mental Illness (SPMI) or addictive disorder diagnosis as measured by the MINI (Mini International Neuropsychiatric Interview), or sleep disorder;
• Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
• Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
Device: Transcranial direct current stimulation (tDCS)
Transcranial Direct Current Stimulation, Healthy
tDCS, cognitive training, functional connectivity, non-invasive brain stimulation
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Increased thalamocortical connectivity in tdcs-potentiated generalization of cognitive training (MINUTES)

The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.

Kelvin Lim
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03896438
STUDY00003506
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Inclusion Criteria:

• Ability to provide consent and comply with study procedures.
• Age 18 - 60 years old.
• Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
• Schizophrenia or schizoaffective disorder as assessed by the MINI (Mini International Neuropsychiatric Interview)(Sheehan et al., 1998).
• Not having a current addictive disorder as measured by MINI (Mini International Neuropsychiatric Interview), or a sleep disorder.
• Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.
• Clinically stable and on stable medications for at least one month before start of study.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
• Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
Device: Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation, Schizophrenia, Schizoaffective Disorder
tDCS, cognitive training, functional connectivity
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Enhanced Spatial Targeting in ECT Utilizing Focally Electrically-administered Seizure Therapy (FEAST)

Twenty ECT eligible TRD patients will receive a course of FEAST with up to 15 sessions (including titration) in an open trial design. Sessions 2,3 and 4 will be cross-randomized between ‘typical’ FEAST electrode configuration, the same electrode placement but a reversed polarity of current flow (RP FEAST) and the reverse electrode configuration FEAST (RC FEAST). Electrophysiological markers of the induced seizure will be captured with a 6-lead EEG placed over bilateral frontal, temporal and parietal lobes.

Ziad Nahas
All
18 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04099342
STUDY00006734
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Inclusion Criteria:

• Diagnosis of major depressive disorder using mini-7 to derive RDC; DSM-IV
• Pretreatment HRSC score greater than or equal to 18
• ECT indicated by physician evaluation
• Willing and capable of providing informed consent as determined by physician evaluation
Exclusion Criteria:

• History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by mini-7; rapid cycling defined as greater than or equal to four episodes in past year
• History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history
• Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation
• Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation
• Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation
• ECT in the past six months determined by physician evaluation and medical history
• Pregnancy as determined by urine pregnancy test and clinical interview
Device: FEAST, Device: FEAST RP, Device: FEAST RC
Treatment Resistant Depression
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Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat

This study is one of three studies on an NIH-funded project addressing the effectiveness of parents in buffering children and adolescents from the physiological and brain responses to stress. This study uses MRI scanning to measure the brain response to social evaluative stress (giving a speech and doing math problems in front of a panel of judges) as well as the impact of the presence of various social partners (no one, researcher, or parent) in buffering the physiological and brain responses to social evaluative stress.

All
11 Years to 14 Years old
N/A
This study is also accepting healthy volunteers
NCT04211155
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Inclusion Criteria:

• sufficient vision to complete assent and study procedures
• sufficient hearing to complete assent and study procedures
• sufficient language skills to provide verbal and written assent
Exclusion Criteria:

• Premature birth (less than 37 weeks)
• congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
• Autism Spectrum Disorders
• history of serious medical illness (e.g., cancer, organ transplant)
• youth taking systemic glucocorticoids
• youth taking beta-adrenergic medications
• diagnoses of psychiatric illness, seizure disorder or other neurological disorders
• contraindications for MRI (implanted medical device; presence of non-removal metal in or on the body, including piercings, orthodontic braces or certain permanent retainers)
• known pregnancy
• tattoos
• history of significant claustrophobia
Other: Questionnaires, Other: MRI
Social Stress, Adolescent Behavior
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Does Social Buffering Continue to be Effective Over the Peripubertal Period When Friends Share the Stressor Experience?

The purpose of this experiment is to determine whether social buffering of stress physiology by friends remains effective later in puberty when the friend shares the load versus when they provide support but are not undergoing the stressor with the target child. There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

All
11 Years to 14 Years old
N/A
This study is also accepting healthy volunteers
NCT04311996
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Inclusion Criteria:

• sufficient vision, hearing, and language skills to provide verbal and written assent
• ability to see and read stimuli presented on the computer screen
• ability to hear verbal instructions provided by the experimenter and judges
Exclusion Criteria:

• premature birth (less than 37 weeks)
• congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
• Autism Spectrum Disorders
• history of serious medical illness (e.g., cancer, organ transplant)
• serious psychiatric illness
• systemic glucocorticoids or beta-adrenergic medication use
Other: Questionnaires, Other: TSST
Adolescent Behavior, Social Stress
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Bupropion for the Prevention of Postpartum Smoking Relapse

Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
This study is also accepting healthy volunteers
NCT04098874
STUDY00007684
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Inclusion Criteria:

• Ability to provide informed consent
• Age 18 to 40 years old
• Stable health
• 7-day point prevalence abstinence demonstrated at randomization
• Lifetime history of at least 100 cigarettes smoked
• Quit smoking during the current pregnancy
• Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• Uncomplicated delivery
• Denies plans to become pregnant again during the trial.
• Full-term delivery ≥ 37 weeks gestation
• Home within 10 days of delivery
Exclusion Criteria:

• Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• Current use of cessation aids (e.g., varenicline, NRT)
• Current use of illicit drugs or alcohol dependence
• Current use of antidepressant medication
• Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
• Medications & conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
• Family history of seizures or seizure disorder
• Maternal use of medications that lower seizure threshold
• Newborn with an elevated risk of seizure
Drug: Bupropion Extended Release Oral Tablet, Drug: Placebo oral tablet
Postpartum Smoking Relapse
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Visual Surround Suppression and Perceptual Expectation Under Psilocybin

The study involves a randomized, double blind, placebo controlled, crossover design with two different groups pairing the psychoactive drug psilocybin, or the active placebo Niacin, with a combination of perceptual tasks. The proposed study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control. We will obtain a psychophysical (behavioral) measurement of the impact of acute psilocybin intoxication on visual surround suppression in healthy human volunteers. Baseline data will be collected as participants complete the perceptual tasks pre-drug administration. Participants will repeat the tasks again three hours and five hours after an oral dose of psilocybin.

Jessica Nielson
All
25 Years to 65 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04424225
STUDY00009765
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Inclusion Criteria:

• Have given written informed consent
• Have at least a high-school level of education or equivalent (e.g. GED), and be able to read and write in English
• General health status: Participants should be in good physical (BMI between 20.0 and
• 0 kg/m2) and psychiatric health.
• Experience taking psilocybin (at the PI's discretion).
• Participants must also have a person that can reliably transport them to and from the CRU for dosing session days.
• Geographic location: Minnesota counties that are approximately within 1 hour driving distance to Twin Cities, including not limited to Hennepin, Ramsey, Washington, Anoka, Wright, Carver, Scott, Dakota, Sherburn
• Participants must be willing to wear a face mask at all times during in-person study visits, except for dosing sessions, to ensure COVID-19 protection.
• Participants must be willing to get a COVID-19 test and share results with the study team prior to all in-person visits.
• Participants must be up-to-date on COVID-19 vaccines, per CDC guidelines, and share a copy of their proof of vaccination status with the study team prior to the consenting visit.
• Agrees to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
Exclusion Criteria:

• Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except due to another medical condition), or Bipolar I or II Disorder, personality disorder, major depressive disorder, posttraumatic stress disorder, panic disorder, obsessive compulsive disorder, dysthymic disorder.
• Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine, nicotine, and hallucinogens)
• Those with a first or second-degree relative with a current or past history of meeting DSM-5 criteria for schizophrenia or other psychotic disorders or bipolar I or II disorder, because they might have an underlying genetic susceptibility for psychosis.
• Presence of symptoms of the following DSM-5 disorders within the past 6 months (as assessed by the MINI-7):
• Major depressive Episode
• Suicidality
• Manic and Hypomanic Episodes
• Panic disorder
• Agoraphobia
• Social Anxiety Disorder
• Obsessive-Compulsive Disorder
• Posttraumatic Stress Disorder
• Alcohol Use Disorder
• Substance Use Disorder (Non-Alcoholic)
• Psychotic Disorders and Mood Disorders with Psychotic Features
• Anorexia Nervosa
• Bulimia Nervosa
• Binge Eating Disorder
• Generalized Anxiety Disorder
• Antisocial Personality Disorder
• Mood Disorders:
• Major Depressive Disorder (MDD)
• MDD with Psychotic Features
• Bipolar I
• Bipolar II
• Other Specified Bipolar and Related Disorder
• Presence of abuse or dependence of drugs measured by the MINI-7 in the past 12 months:
• Lithium, Sodium Valproate (Depakote), Lamotrigine (Lamictal) - Manic/Bipolar disorders
• Stimulants: amphetamines, "speed", crystal meth, "crank", Dexedrine, Ritalin, diet pills.
• Cocaine: snorting, IV, freebase, crack, "speedball".
• Opiates: heroin, morphine, Dilaudid, opium, Demerol, methadone, Darvon, codeine, Percodan, Vicodin, OxyContin.
• Dissociative Drugs: PCP (Phencyclidine ,"Angel Dust", "Peace Pill", "Hog"), or ketamine ("Special K").
• Inhalants: "glue", ethyl chloride, "rush", nitrous oxide ("laughing gas"), amyl or butyl nitrate ("poppers").
• Cannabis: marijuana, hashish ("hash"), THC, "pot", "grass", "weed", "reefer".
• Sedatives, Hypnotics or Anxiolytics: Quaalude, Seconal ("reds"), Valium, Xanax, Librium, Ativan, Dalmane, Halcion, barbiturates, Miltown, GHB, Roofinol, "Roofies".
• Miscellaneous: steroids, nonprescription sleep or diet pills. Cough Medicine?
• History of medication or substance induced psychosis.
• Medically significant condition considered unsuitable for the current study (e.g. diabetes, epilepsy, severe cardiovascular disease, etc)
• History of suicide attempts or mania
• Positive pregnancy test or currently breast-feeding
• Currently taking on a regular (e.g., daily) basis any prescription medications, with the exception of birth control or other hormone therapy
• A strong bias either for or against psychedelic substances, or if their responses about psychedelic use indicate that they abuse them from frequent use (more than once per month, with the exception of microdosing).
• MRI EXCLUSION: we will also exclude anyone with head trauma, claustrophobia incompatible with scanning, cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant, prior history as a metal worker and/or certain metallic objects in the body that cannot be approved for MR scanning by the CMRR safety committee, history of clinically significant vertigo, seizure disorder, middle ear disorder, or double vision, or tattoos that were done less than 4 weeks from the first scheduled MRI.
• Significant movement disorders including tardive dyskinesia that could disrupt EEG recordings will also be excluded.
• Uncontrolled hypertension, with an average blood pressure reading across 4 measurements over 2 separate days greater than 140/90mmHg.
• Unwilling to wear a face mask during in-person study visits that require them.
• Unwilling to get tested for COVID-19 and share results with study personnel prior to all in-person visits.
• Are unvaccinated against COVID-19, are not current with their COVID-19 vaccine booster, or are unwilling to share their proof of COVID-19 vaccination with the study team.
Drug: Psilocybin, Drug: Niacin
Perception Disturbance, Visual Suppression, Psychedelic Experiences
psilocybin, visual perception
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Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

This study will enroll adults who are currently in a methadone treatment program and clinically stable in a randomized, double-blind, transcranial direct current stimulation (tDCS) intervention (active or sham) trial study. The primary study aim seeks to examine whether pairing non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) with cognitive training, as a therapeutic intervention can enhance cognition and reduce relapse rates in opioid use disorder. The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder.

All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04495673
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Inclusion Criteria:

• Current diagnosis of opioid use disorder
• Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
• Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
• Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
• Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
• Head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
• Any contraindications for tDCS or MRI scanning (tDCS contraindication: actively receiving treatment for seizures or epilepsy; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
• Current active psychosis or mania
• Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
• History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
• incarceration
Device: Transcranial Direct Current Stimulation (tDCS), Device: Sham Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive Training
Opioid-Related Disorders, Heroin Dependence, Morphine Dependence
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Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

All
11 Years to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04562688
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Inclusion Criteria:

• Potential participant is between the age of 11 and 18 (inclusive) at the time of consent.
• Potential participant has a clinical diagnosis of Autism Spectrum Disorder (ASD), as confirmed by medical/clinical records or standardized assessments/interviews (e.g., Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) or Autism Diagnostic Interview - Revised (ADI-R)).
• Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records.
• Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported.
• Potential participant has normal hearing (self/parent-reported).
• Potential participant is a fluent English speaker, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician, to ensure reasonable neuropsychological results on key assessments.
• Potential participant has adequate sensorimotor capacity to perform the intervention and study activities, including visual capacity adequate to read from a computer screen or mobile device at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician and/or study team.
• Potential participant must be clinically stable as a result of therapy or medication regimen for 4 weeks prior to enrolling into the study.
• Potential participant has reliable access to the internet.
Exclusion Criteria:

• Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years.
• Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team.
• Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team.
• Potential participant has medical illnesses/genetic syndromes deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment.
• Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
• Potential adult participant scores less than a 14 (75%) on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). Please note, this criteria applies only to adult participants, age 18, at the time of screening.
Other: CICADAS and then PEERS, Other: PEERS + CICADAS and then no-contact, Other: PEERS + Active Comparator and then no-contact
Autism Spectrum Disorder
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Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks

This study will examine the effects of non-invasive, transcranial electric stimulation (TES) on neural activity during a cognitive task or rest using invasive recordings in patients undergoing phase II epilepsy monitoring.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04680481
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Inclusion Criteria:

• the patient can consent for themselves;
• the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation;
• age 18+ years old;
Exclusion Criteria:

• diminished capacity to consent;
Device: Transcranial alternating current stimulation
Working Memory
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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy? System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD. The objective of this study is to determine whether active VNS Therapy treatment improves health outcomes for Treatment Resistant Depression (TRD) subjects compared to a no stimulation control in depressive symptoms. This prospective, multicenter trial is composed of two parts: - The RCT and Follow-up (RCT) is a randomized, controlled, blinded trial to determine if active VNS Therapy treatment compared to a no stimulation control improves depressive symptoms. - The Longitudinal Registry (LR) is an observational, open label, single arm study aimed at assessing the long-term effectiveness and safety of VNS Treatment.

Ziad Nahas
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03887715
STUDY00009412
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Inclusion Criteria:
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose. The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device. Patients must maintain a stable medication regimen for at least four weeks before device implantation.
Exclusion Criteria:
Current or lifetime history of psychotic features in any MDE; Current or lifetime history of schizophrenia or schizoaffective disorder; Current or lifetime history of any other psychotic disorder; Current or lifetime history of rapid cycling bipolar disorder; Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder; Current suicidal intent; or Treatment with another investigational device or investigational drugs.
Device: Vagus Nerve Stimulation (VNS)
Treatment Resistant Depression
VNS, Depression, TRD
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Impact of low nicotine cigarette messaging on risk perceptions and hypothetical tobacco and nicotine product choices.

The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.

Dana Carroll
All
21 Years and over
Early Phase 1
This study is also accepting healthy volunteers
NCT04740008
STUDY00012495
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Inclusion Criteria:

• Male or female
• At least 21 years of age
• Biochemically confirmed smoker
Exclusion Criteria:

• Unstable health condition
• Unstable medications
• Pregnant or nursing
• Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires
Drug: Low Nicotine Content Cigarettes, Other: Control message, Other: Test message
Smoking, Cigarette
Low Nicotine Content, Educational Messaging, Cigarette, Smoking
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Targeting individual alpha frequencies to enhance perceptual timing

Study of transcranial alternating current stimulation (tACS) in participants with a diagnosis of psychosis and healthy controls.

Ian Ramsay
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04856657
STUDY00012304
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Inclusion Criteria:
Symptoms of psychosis or healthy adult without a mental health condition 18-64
Exclusion Criteria:
Not actively suicidal Clinically stable (stable medication and no recent hospitalizations) No history of seizures, epilepsy, brain surgery No eczema on scalp
Device: Transcranial alternating current stimulation
Psychosis, Schizophrenia, Schizo Affective Disorder, Mental Health & Addiction
tacs, neuromodulation, psychosis, schizophrenia, Healthy Participants, Psychosis, Schizoaffective Disorder, Schizophrenia
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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

We will conduct a double-blind, placebo-controlled, randomized clinical trial at two sites to enhance the diversity of the study sample and generalizability of the results. We will enroll healthy pregnant women (n=320) who have recently quit smoking and intend to stay abstinent postpartum. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog + DMPA, (2) Prog + placebo, (3) placebo + DMPA, and (4) placebo + placebo. Participants will be followed for days to smoking relapse (primary outcome), smoking relapse-related risk factors (e.g., craving), and infant health outcomes from gestational week 36 through 9 months postpartum. This study proposes a safe and innovative intervention to examine the impact of manipulating postpartum physiological to influence the behavior of a new mother which will lead to improved health outcomes for her and her infant. The implications of this novel study will directly advance the current state of the science by expanding on the role of Prog and DMPA in addressing smoking-related behaviors within this highly vulnerable population. Further, should our central hypothesis be supported, the clinical translatability of this intervention is high and may be immediately pursued.

Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04783857
STUDY00010569
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Inclusion Criteria:

• stable physical and mental health with confirmed, uncomplicated pregnancy at gestational week 30-35
• established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider
• self-report of a minimum of 4 weeks of smoking abstinence with confirmation of acute abstinence by expired carbon monoxide level of ≤ 5 ppm at the time of enrollment
• history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months
• self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• willingness to use non-hormonal contraceptives postpartum if sexually active until 12 weeks postpartum
Exclusion Criteria:

• current use of tobacco products (e.g., cigars, e-cigs), nicotine replacement therapy or smoking cessation medications
• current major depressive disorder based on the Structured Clinical Interview for DSM-5 (SCID)
• contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy)
• contraindications to DMPA treatment (e.g., current use of aminoglutethimide or planning to become pregnant in the next year)
• current use of illicit drugs or alcohol abuse
• treatment for illicit drug use or alcohol use disorder within the last 3 months
• any condition that, in the opinion of the clinical team, precludes participation in the trial.
Drug: Progesterone 200 MG Oral Capsule, Drug: Depot-Medroxyprogestereone Acetate, Other: Placebo Oral Tablet, Other: Placebo Injection
Smoking, Smoking Cessation, Smoking Reduction
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Telehealth study assessing the removal of filter ventilation on smoking behavior and biomarkers

This single-blind, between-subject, randomized, multi-center study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study uses telehealth and brief in-clinic or curbside visits and will also examine the feasibility of remote collection of multiple biological samples. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic at a brief clinic or curbside visit where the study cigarettes will be dispensed. Smokers using conventional cigarette brands with filter ventilation of about 16-36% will enter a three phase study. Phase 1 is a 1-week baseline period of smoking usual brand cigarettes; Phase 2 consists of 2 weeks of smoking ventilated cigarettes; and Phase 3 where subjects are randomly assigned to one of two conditions: 1) ventilated cigarettes; or 2) unventilated cigarettes smoked for a 6 week period. Weekly telehealth visits are conducted to collect study measures and subjects attend a brief clinic or curbside visits to pick up study cigarettes and drop off biomarker samples. A follow-up telehealth visit will occur at one-month post intervention.

Dorothy Hatsukami
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04969783
STUDY00012328
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Inclusion Criteria:
-21 years old or greater -Current smoker -Generally in good health -Access to smartphone or tablet -Device capable of Telehealth visit
Other: Ventilated Cigarette Filter, Other: Unventilated Cigarette Filter
Tobacco Use, Mental Health & Addiction
cigarette smoking, filter ventilation, Filter, Nicotine, Policy, Regulatory, Smoking, Tobacco, Ventilation
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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers (PRINCE)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601506
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population (PRINCE)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601493
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population (PRINCE)

A clinic-randomized study of behavioral economics-inspired "nudges" build into the the electronic health record system, with the goal of improving opioid prescribing decisions.

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601480
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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Intravenous Subanesthetic Repeated Dose of Ketamine in Treatment Resistant Depression: A Pilot Study

The overall objective of this proposal is to determine the efficacy of a single vs. multiple sub-anesthetic IV ketamine infusions for patients with TRD. We plan to conduct a randomized controlled trial (RCT) comparing a single ketamine infusion preceded by 5 midazolam infusions vs. six ketamine infusions.

Kelvin Lim
Phase II
This study is NOT accepting healthy volunteers
NCT02360280
1306M36501
Treatment-resistant Depression
Depressive Disorder, Treatment-Resistant
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An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

The purpose of the current study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy for adolescent depression (interpersonal psychotherapy, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week SMART conducted in an outpatient community mental health clinic. Adolescents will be randomized to the IPT-A ATS condition (N=134) or the community clinic’s usual care (UC) (N=66). The aims of this R01 are to (1) evaluate the effectiveness of the ATSs embedded in this trial, (2) evaluate adolescents’ interpersonal functioning as a treatment target of IPT-A, (3) evaluate moderators of initial treatment and treatment augmentation strategies, and (4) conduct a process evaluation to identify barriers and facilitators that influenced ATS implementation.

Meredith Gunlicks-Stoessel
Phase II
This study is NOT accepting healthy volunteers
NCT03222570
STUDY00000460
Depressive Disorder
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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

Treatment-resistant depression (TRD) is a leading cause of premature mortality and healthcare costs. Negative stimuli capture the attention of depressed patients. The more entrenched these core attentional processes are, the longer patients remain ill. The parietal Late Positive Potential (LPP) [an event-related potential (ERP) measured by electroencephalography (EEG)], reliably captures biased attention and early affective responses to environmental stimuli. LPP is top-down modulated by the prefrontal cortex (PFC), an important target for depression treatment. Using a combination of anatomical, functional and electric-field simulation localization methods, we will stereotactically implant 15 TRD patients with bilateral EpCS in a 2-phase approach. First (R61; n=5), we will evaluate EpCS target engagement by observing LPP responses to a series of programing steps on a prescribed schedule. We will utilize a Bayesian optimization algorithm to iteratively modify these parameters to demonstrate that the reduction in LPP response can be induced and maintained over time (Go/No Go Milestone). Completion of the Go/No Go Milestone and approval for additional funding by the NIH will permit the initial of phase 2. In the second phase (R33; n=10), we will confirm target engagement, reduction of LPP response as well as examine the relationship between reductions in LPP and changes in depressive symptoms in TRD patients.

Ziad Nahas
All
21 Years to 55 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04124341
STUDY00006945
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Inclusion Criteria:

• Participant has a diagnosis of chronic (greater than or equal to 2 years) depressive episode as defined by DSM V criteria
• Participant has not had an adequate response to three or more adequate antidepressant treatments from at least two different antidepressant treatment categories in the current depressive episode according to the Antidepressant Treatment History Form (ATHF)
• Participant must have had ECT or refused to undergo ECT if clinically indicated to them
• Participant must have HRSD greater than or equal to 20
• Participant must be able to complete the evaluations needed for this study including the functional imaging scans and the EEG Bayesian optimization sessions
Exclusion Criteria:

• The EpCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
• Participant is expected to require full body magnetic resonance imaging (MRI) during the clinical study
• Participant is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the EpCS implant the participant has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide or scores 14 or higher on the SSI)
• In addition to the acute suicidal risks mentioned above, participant meets any of the following:
• Has made a suicide attempt within the previous 12 months that required medical treatment
• Has made greater than or equal to two suicide attempts in the past 12 months
• Has a clear-cut plan for suicide that states that she/he cannot guarantee that she/he will call her/his regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study
• Is likely to attempt suicide within the next six months, in the Investigator's opinion
• Participant has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria
• Participant with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) less than or equal to 23
• Female participant with a positive urine pregnancy test
• Participant with a positive urine drug screen
• Participant with DBS
• Participant with VNS if the device was active in the last 6 months prior to study enrollment
Device: Prefrontal Cortical Stimulation (PCS)
Treatment Resistant Depression
Clinics and Surgery Center (CSC)
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Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs

In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota, Minneapolis VA, and Allina Health (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.

Anne Joseph
NA
This study is NOT accepting healthy volunteers
NCT02597491
1506M74221
Smoking
Lung cancer screening, Sequential, multiple assignment, randomized trials (SMART), Smoking cessation, Smoking,
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