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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

Recruiting

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 22-55 years old with Medicare or Medicare Advantage insurance.

I'm interested

All
22 Years to 55 Years old
This study is NOT accepting healthy volunteers
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
• Participant must be under the care of a licensed psychiatrist, undergoing regular care evaluations, and inform study team of any change to care team during study participation
• Participant must agree to allow all forms of communication between investigators and study staff and any health care provider (current or having provided service within two years of enrollment)
• Participant must provide name and contact information for at least two people greater than or equal to 22 in age who reside within a 30 minute drive of the participant's residents and whom staff may contact as necessary during study participation
• Participant must be enrolled in a Medicare program
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
• 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
• Participant with history of seizures

Device: Prefrontal Cortical Stimulation (PCS)

Treatment Resistant Depression

Clinics and Surgery Center (CSC)

Interventional Psychiatry Lab Study - ipl@umn.edu
Ziad Nahas
N/A
STUDY00006945
STUDY00006945
See this study on ClinicalTrials.gov

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