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Search Results Within Category "Mental Health & Addiction"

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28 Study Matches

Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization

This study is testing a new digital tool designed to help people who smoke during a quit attempt. The tool is a conversational program that uses artificial intelligence to provide personalized support and suggestions when people are facing situations where they might be more likely to smoke. The goal of the study is to see how easy the tool is to use, whether people find it helpful, and whether it may support smoking cessation.

Principal Investigator: Michael Kotlyar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026782
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 21 years of age or older
• identify as Black or African American
• currently smoke cigarettes and meet minimum smoking requirements for the study
• willing to make a quit attempt within the next 30 days
• see link to ClinicalTrials.gov for complete inclusion criteria
Exclusion Criteria:

• current use of prescription nicotine medications requiring clinical monitoring
• medical conditions or medications that may significantly interfere with smoking behavior or study participation
• pregnant or breastfeeding
• see link to ClinicalTrials.gov for complete exclusion criteria
Conditions: Mental Health & Addiction
Keywords: nicotine, Smoking cessation
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COgnitive STrategies in Early Psychosis 1 (COSTEP 1)

This study is about decision making in psychosis spectrum disorders, like schizophrenia. We will study how a single dose of a study agent called modafinil changes how people complete computer tasks and changes how the brain functions. We hope to improve our understanding of psychosis to help people in the future.

Principal Investigator: Sophia Vinogradov
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00025500
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 35 years old
• speak English as primary language
Exclusion Criteria:

• major medical diagnosis such as neurological disorder, kidney, heart, liver disease
• people who are pregnant, breastfeeding, or planning to become pregnant
• have a diagnosis or immediate family history of a psychotic, bipolar, or autism spectrum disorder
• study staff will review additional criteria
Conditions: Mental Health & Addiction
Keywords: mental health

Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms

This study includes healthy adults between the ages of 21-70 who either use or do not cannabidiol (CBD) regularly. The purpose of this study is to learn about how CBD users and nonusers respond to stress. Participants must be willing to attend one in-person visit at the University of Minnesota Duluth campus

Principal Investigator: Mustafa al'Absi
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024552
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 21 to 70 years old
• generally healthy
• use CBD regularly or do not use CBD
• willing to attend one in-person visit at the University of Minnesota campus
Exclusion Criteria:

• current, unstable physical or mental health condition
• women who are currently pregnant
• current use of illicit substances (other than cannabis)
Conditions: Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
Keywords: Minneapolis, Twin Cities, UMN, Cannabidiol, CBD, stress
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALTO-300 WITH AN OPEN-LABEL EXTENSION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER

The purpose of this study is to evaluate the safety and effectiveness of ALTO-300, an investigational medication being studied for adults with Major Depressive Disorder (MDD). This study will compare ALTO-300 to a placebo to learn more about how the medication may improve symptoms of depression and to identify factors that may help predict who is most likely to benefit from treatment.

Principal Investigator: Cristina Albott
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027511
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 18-70 years old
• diagnosed with moderate to severe major depressive disorder (MDD)
• currently taking one approved antidepressant medication (SSRI, SNRI, or bupropion) for at least 6 weeks with no recent dose changes
Exclusion Criteria:

• diagnosed with fibromyalgia
• pregnant or breastfeeding
Conditions: Mental Health & Addiction
Keywords: agomelatine, ALTO-300, depression, Major Depressive Disorder, MDD
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Assessing Changes in Knowledge and Attitudes Toward Transcranial Magnetic Stimulation (TMS) After a Demonstration-Based Intervention

The purpose of this study is to learn whether watching a short educational video changes what people know and think about transcranial magnetic stimulation (TMS), a non-medication treatment for depression that uses magnetic pulses. Researchers will also compare different video styles to determine which is most effective at increasing knowledge and improving attitudes about TMS.

Principal Investigator: Jeremy Chaikind
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00028471
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 18+
Conditions: Mental Health & Addiction
Keywords: Survey, MNFair
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Emotion Regulation Knowledge Study

The purpose of this study is to develop and evaluate a storybook-based tool that measures how children ages 4 and older understand and manage their emotions. Researchers will examine how children choose different emotion regulation strategies in a variety of situations, such as interactions with family, friends, or when alone, and how these skills relate to children's social and emotional development.

Principal Investigator: Ka Ip
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00026826
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• children ages 4–12 years
• parent or legal guardian able to provide informed consent
• child and parent willing to participate in a single research visit involving an iPad-based storybook activity and a brief parent survey
Conditions: Children's Health, Mental Health & Addiction
Keywords: Child development, Emotion regulation, Social-emotional development, MNFair, iPad-based activities
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Neural Bases of Disgust Conditioning in Anorexia Nervosa

We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.

Principal Investigator: Lisa M Anderson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00009646
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
Exclusion Criteria:

• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
Conditions: Mental Health & Addiction
Keywords: Anorexia, Eating Disorder, Mental Health
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Technology Assisted Treatment for Binge Eating Disorder

This research is being done to study binge eating and potential treatment strategies. An app on a sensor logging device will log eating behavior data. The device will incorporate data and refine the performance of the HabitAware sensor logging model to recognize binge eating episodes. We hope this research will help inform novel treatments for targeting binge eating behavior.

Principal Investigator: Carol Peterson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018933
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults between the ages of 18 and 65 years
• diagnosis of bulimia nervosa, binge eating disorder, or other eating disorder
Exclusion Criteria:

• women who are pregnant or breast feeding
• history of psychosis or bipolar disorder
• substance use disorder within the past six months
• BMI less than 18.5 kg/m2
• history of acute suicidality requiring hospitalization
• food allergies
Conditions: Mental Health & Addiction
Keywords: Binge Eating Disorder
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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-70 years old with Medicare or Medicare Advantage insurance.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006945
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
Exclusion Criteria:

• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Chronic Depression, Depression
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Characterizing Neuropathic Pain in Individuals Receiving Inpatient Treatment for an Alcohol Use Disorder

This study aims to learn more about neurological symptoms associated with alcohol use. The study team plans to characterize neuropathic pain in individuals receiving in-patient treatment for alcohol use compared with moderate drinkers of the same age.

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
IRB Number: STUDY00025425
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• between 21 and 65 years of age
• must speak English
• Moderate drinkers group: Use alcohol at least 2-4 times per month
• Treatment group: patients in the Fairview Lodging Program primarily seeking treatment for alcohol - use of nicotine, cannabis, cocaine, and hallucinogens are permissible
Conditions: Brain & Nervous System, Mental Health & Addiction
Keywords: alcohol use, Pain, sensation
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Using MRI Scans to Inform Individualized Neuromodulation Interventions in Major Depressive Disorders with and without Comorbidities

This study collects MRI brain scans before, during, and after treatment in people with depression and other mental health conditions who are receiving neuromodulation therapies. The goal is to see whether differences in brain structure can help explain why some people respond to treatment better than others.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027225
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• seeking clinical or research neuromodulation interventions for depression (with or without comorbidities)
• able to read English
Exclusion Criteria:

• cannot complete MRI
Conditions: Mental Health & Addiction
Keywords: depression, MRI, neuromodulation
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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: R33 Phase

This study will look at the effects of treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and Transcranial Magnetic Stimulation (TMS) for young people who have tic disorder. Participants must be 12- 21 years old and able to have an MRI. All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered to be the first treatment for tics. Participants will also be assigned randomly (by chance) to receive TMS or a sham (treatment not delivered) just before each CBIT session. The device for TMS delivers electromagnetic stimulation to a specific area of the brain with a small coil on the scalp. The effectiveness of the CBIT for the two groups, with and without the TMS, will be compared.

Principal Investigator: Christine Conelea
Age Group: 12 years to 21 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023755
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Sex: Male or Female
Age Group: 12 years to 21 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between the ages of 12 – 21
• currently experiencing chronic motor and/or vocal tics
• able to undergo MRI
• study staff will review additional exclusion criteria
Exclusion Criteria:

• currently receiving therapy focused on tics
• currently taking neuroleptic/antipsychotic medications
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: TMS, Tourette's syndrome, Vocal tics, CBIT, Motor tics, Tic Disorder
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Neural Mechanisms of Closed-loop Phase-locked Transcranial Magnetic Stimulation

We are investigating ways to improve methods of brain stimulation. The purpose of this study is to try a new way to deliver transcranial magnetic stimulation (TMS) to the brain. Participants will be asked to come in for three separate 4-hour research visits. Each research visit will take place approximately seven days after the previous one. During the research visits, we will put a mesh cap on the head to measure electrical activity in the brain (also known as an EEG). Once the cap is on, we will use a transcranial magnetic stimulation (TMS) device to deliver small pulses of electricity to the brain to see how it reacts to the stimulation.

Principal Investigator: Alik Widge
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020385
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• adults (Age 18 to 65) without any psychiatric diagnoses
• adults (Age 18 to 65) with depression diagnosis
Exclusion Criteria:

• diagnosed with a psychiatric disorder other than depression
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of or recent withdrawal from medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or an implanted medical device
Conditions: Mental Health & Addiction
Keywords: brain stimulation, EEG, healthy control, TMS, transcranial magnetic stimulation, depression
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State Representation in Early Psychosis 2

In this study, participants will complete two to three appointments within two weeks. During these appointments, they will complete interviews and questionnaires about their life experiences and mental health. An EEG test will also be conducted while they complete computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis spectrum disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

Principal Investigator: Scott Sponheim
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00024589
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 15 to 45 years old
• able to speak and write English
• no hospitalizations and on stable doses of medications for the past one month or more
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis
• matched healthy volunteers
Exclusion Criteria:

• previous clinically significant head injury
• severe substance or alcohol use within past 3 months - major neurological disorder - medical condition that would interfere with participation
• currently at risk for suicidal behavior
Conditions: Mental Health & Addiction
Keywords: Psychosis, Schizoaffective Disorder, Schizophrenia
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Neurobehavioral Impacts of Medical Cannabis Treatment in Chronic Pain Patients Neurobehavioral Impacts of Medical Cannabis Use: An Observational Study

This study is part of our ongoing program of research to understand how the brain and behavior are impacted by cannabis use. We are particularly interested in whether the use of medical cannabis products in adulthood has impacts on learning skills, other aspects of cognition such as memory, attention, and behavioral control, and whether the brain circuits that control these functions change within four months of treatment initiation. Individuals between the ages of 30 and 75 years will be studied at the start of treatment with the plan to retest participants after four months.

Principal Investigator: Monica Luciana
Age Group: 18 years and over
IRB Number: STUDY00011239
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• chronic pain (not cancer-related)
• prescribed medical cannabis for chronic pain
• must begin the study before taking the first medical cannabis treatment dose
• age 30-75
• native English speaker
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• recreational cannabis use
• regular nicotine use
• can't have a MRI
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Mental Health & Addiction
Keywords: chronic pain, Medical cannabis, medical marijuana, THC
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Neural Correlates of Pain and Alcohol Consumption in Chronic Temporomandibular Disorder (TMD)

The purpose of this research is to better understand how alcohol impacts pain processing in people with Temporomandibular Disorder (TMD) using MRI technology.

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
IRB Number: STUDY00022066
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Age Group: 18 years and over
Inclusion Criteria:

• 21 years of age or older
• report regular drinking
• have a diagnosis of a Temporomandibular Disorders
Exclusion Criteria:

• diagnosis of Alcohol Use Disorder
Conditions: Brain & Nervous System, Dentistry, Mental Health & Addiction
Keywords: Alcohol, MRI, Orofacial Pain, Temporomandibular Disorders (TMD)
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Causal inference and impact of prior beliefs on perception

The study is being conducted in order to further understand how we perceive the world, and if and how this may be different in individuals on the autism spectrum. We hope to further understand sensory processing differences in autism.

Principal Investigator: Jean-Paul Noel
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00022626
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Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 14to 36 years old
• right-handed
• normal (or corrected) vision - normal hearing
• able to sit quietly and make judgments of sensory stimuli
• diagnosis of Autism
Exclusion Criteria:

• history of epilepsy
Conditions: Brain & Nervous System, Mental Health & Addiction, Vision & Eyes
Keywords: ASD, autism, decision-making, EEG, multisensory integration, perception, self-motion, sensation
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Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Principal Investigator: Ida-Arlaine Fonkoue
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014457
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• female
• 18 years and older
• pre-menopausal
• must have experienced a past trauma, with or without PTSD Diagnosis
Exclusion Criteria:

• pregnant or breastfeeding
• severe traumatic brain injury
• hypertension
• diabetes
• heart disease
• vascular disease
• illicit drug use within the past 6-months prior to participation
• inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3
Conditions: Mental Health & Addiction, Women's Health
Keywords: Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People with Chronic Temporomandibular Disorder (TMD) Pain (TMD)

This study is about the impacts of pain, temporomandibular disorders (TMD), on individual drinking patterns.

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00023834
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 21+ years of age, with a valid ID
• Fluent in English
• At least 1 drink 3 days/week over the past six months
• Diagnosis of TMD, myalgia, TMJ, or a combination
• Have a smartphone with Internet
Exclusion Criteria:

• History of any psychotic disorder, current major depression, substance use disorder or current alcohol use disorder
• Serious medical illness
• Under-controlled hypertension or diabetes or neurological disease
• Impaired cognitive function
• Women who are pregnant breastfeeding, or intending to become pregnant
• Loss of sensation in lower legs or physical inability to complete study tasks
• Positive drug screening
• Medications that contraindicate alcohol use
• Comparison group: Chronic pain & TMD
Conditions: Bone, Joint & Muscle, Brain & Nervous System, Mental Health & Addiction
Keywords: Alcohol, Questionnaires, TMD/ TMJ, Virtual Reality
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Brain Training for Substance Use Disorders

Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.

Principal Investigator: Justin Anker
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001900
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 65 years of age
• admitted to Fairview's Lodging Plus program for chemical dependency treatment with opioid use being the primary reason
• able to read at a minimum of a 6th grade reading level
• willing to provide own contact information for follow-up visit(s)
• for HEALTHY CONTROLS: 18 to 65 years old, able to read at a minimum of a 6th grade reading level, and willing to provide own contact information for follow-up visit(s)
Exclusion Criteria:

• pregnancy
• history of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures)
• unable to see text and photos clearly on a computer display
• current or previous problems using opioids, other prescription (prescribed or not prescribed) or illicit drugs
• regular nicotine user (e.g., cigarette smoker, e-cig user) within the past 12 months and
• unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary
Conditions: Brain & Nervous System, Mental Health & Addiction
Keywords: biofeedback, brain games, brain training, neurofeedback, noninvasive eeg, substance use, wearables
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Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior

This study is being done to better understand how the brain and impulsive decision-making are connected to depression and suicidal behaviors in people ages 13-21. Participants will complete clinical assessments, behavioral measures, undergo an MRI scan and complete transcranial magnetic stimulation with electroencephalography (TMS-EEG). There will be follow-ups at 6 and 12 months.

Principal Investigator: Kathryn Cullen
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020551
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 13-21 years of age
• current unipolar depressive episode
• lifetime history of suicidal ideation OR suicidal behavior
Exclusion Criteria:

• lifetime history of psychosis, hypomania, mania
• historical diagnosis of autism spectrum disorder or intellectual disability
• pregnancy
• neurological disorders
• MRI contraindications (metal implants, fragments or devices)
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: adolescents, Depression, mental health, suicide, teens

Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease

A pilot study looking at an adult-based non-pharmacologic interventional trial in collaboration with psychologist who has expertise in cognitive behavioral therapy (CBT) for adolescents with chronic disease and intellectual disability and developing processes towards independence in non-Sickle Cell Disease settings.

Principal Investigator: Alexander Boucher
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018692
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 28 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
Exclusion Criteria:

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Conditions: Blood Disorders, Mental Health & Addiction
Keywords: SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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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)

The purpose of this study is to determine whether active Vagal Nerve Stimulation (VNS) Therapy is better than no stimulation VNS Therapy in improving health outcomes for subjects with Treatment-Resistant Depression (TRD). All participants in this study will receive a VNS Therapy surgical implant, which works to reduce the symptoms of depression by sending mild electrical pulses to the vagus nerve in the neck. The vagus nerve is connected to areas of the brain associated with controlling the mood. Data will be collected on responses to study treatments, quality of life, productivity, and use of healthcare services.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000818
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• current diagnosis of major depression for at least two years or at least 4 episodes of major depression
• have an inadequate improvement in symptoms with at least 4 antidepressant treatments
• on at least one antidepressant with a stable drug schedule for at least 4 weeks
• enrolled in Medicare or Medicare Advantage
Exclusion Criteria:

• Currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
• acute suicide risk or suicide attempt within 6 months
• history of other major mental health diagnosis (staff will review)
• treatment with another device or experimental drug
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Depression, Major depression

Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Principal Investigator: Sonya Wang
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020174
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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MRI for TMS Targeting

This research study is investigating how individual differences in brain structure and function might influence neuromodulation treatment outcomes for psychiatric conditions. Participants in this study will come in for a single MRI scan before receiving Transcranial Magnetic Stimulation treatment at the St. Louis Park Interventional Psychiatry Clinic. After that, the research team will analyze the MRI to see if we can make any conclusions about how brain structure and function relate to treatment outcomes.

Principal Investigator: Alik Widge
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015452
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 13 or older
• seeking TMS Treatment at St. Louis Park Neuromodulation Clinic
• able to read English
Exclusion Criteria:

• history of unprovoked seizures
• contraindications for receiving MRI such as implanted devices in body
• currently has braces that cannot be removed or will not be removed by the time the study visit is scheduled
• severe claustrophobia (fear of closed spaces)
Conditions: Mental Health & Addiction
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Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa

The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).

Principal Investigator: Carol Peterson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00010436
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
Exclusion Criteria:

• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
Conditions: Mental Health & Addiction
Keywords: Bulimia Nervosa

Focus in NeuroDevelopment (FIND) Network: A Statewide Network for Research in Neurodevelopment

The purpose of this research project is to develop a registry and database of families with neurodevelopmental disorders.

Principal Investigator: Amy Esler
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: 1306M35301
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• All ages
• All individuals with disabilities and families within the neurodevelopmental disorder community
• Also looking for clinicians, educators, and professionals in the field
Conditions: Children's Health, Mental Health & Addiction
Keywords: autism, OCD, ADHD, tic disorders, neurodevelopment, community outreach
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COgnitive STrategies in Early Psychosis 2 (COSTEP 2)

This study looks at decision-making and brain function in people with psychosis spectrum disorders, such as schizophrenia. By joining this study, you can help us better understand how the brain makes decisions in psychosis. What we learn may help guide better treatments for people with psychosis in the future.

Principal Investigator: Sophia Vinogradov
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025575
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Hide eligibility criteria
Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between 18 and 35 years old
• diagnosis of a psychosis-related condition, such as schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis, within the past 5 years
• taking stable psychiatric medications with no major medication changes within the past month
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have a serious medical, neurological, heart, kidney, or liver condition that could make participation unsafe
• are pregnant, planning to become pregnant, or breastfeeding
• take certain medications or supplements that may not be safe with the study medication, or have had a serious reaction to modafinil or another medication
• have a recent serious alcohol or substance use problem, a history of stimulant use disorder, or current concerns about suicide risk
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Mental Health & Addiction
Keywords: Psychosis, Schizophrenia, Bipolar Disorder, Bipolor, Mental Health, Psychiatric
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See this study on ClinicalTrials.gov