BridgeMD
New treatment option for Treatment Resistant Depression
Official title PCS in Severe Treatment Resistant Depression
ClinicalTrials.gov ID: NCT04124341
What this study is testing
- What it's testing
- This research study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. Participants receive intermittent electrical stimulation to the brain, which involves surgically placing electric leads in between the tough fibrous membrane covering the surface of the brain and the surface of the brain itself.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- Participant must be able to provide written informed consent.
- 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 four or more adequate antidepressant treatments from at least two different antidepressant treatment...
- Participant must have had ECT (Electroconvulsive Therapy) or refused to undergo ECT if clinically indicated to them
- Participant must have HRSD greater than or equal to 20 at study entry
You likely can't join if
- The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
- Participant is unable to undergo required 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 PCS implant the participant has made a suicide...
- 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
See the full eligibility criteria
Who can join
- Participant must be able to provide written informed consent.
- 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 four or more adequate antidepressant treatments from at least two different antidepressant treatment categories in the current depressive episode according to the...
- Participant must have had ECT (Electroconvulsive Therapy) or refused to undergo ECT if clinically indicated to them
- Participant must have HRSD greater than or equal to 20 at study entry
- 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...
- Participant must be enrolled in a Medicare program
What rules you out
- The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
- Participant is unable to undergo required 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 PCS implant the participant has made a suicide attempt or gesture or has made specific plans or preparation to...
- 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)...
- 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 (Deep Brain Stimulator)
- Participant with VNS (Vagus Nerve Stimulator) if the device was active in the last 6 months prior to study enrollment
- Participant with history of seizures
- Participant determined by surgical safety committee to have cerebral atrophy, neurodegenerative or neurovascular disease due to age or medical condition that would prohibit optimal surgical safety, per clinical MRI
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.