Depressive Disorder, Major study: RTMS therapy
Official title Biomarkers of Depression and Treatment Response
ClinicalTrials.gov ID: NCT04581902
What this study is testing
- What it's testing
- The study aims to discover brain imaging and electrical activity markers that identify major depression and predict response to transcranial magnetic stimulation (TMS).
- Who it's for
- Adults who have been diagnosed with major depressive disorder.
- What's involved
- Participants will receive TMS therapy and undergo multiple brain scans and electrophysiology tests to track changes over time.
- Time commitment
- The study runs for the length of the TMS treatment course, requiring several visits for imaging and monitoring.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70
- Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without...
- Has Montgomery-Asberg Depressive Rating Scale (MADRS) of \> 19 at baseline, corresponding with moderate to severe depression.
- Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.
- If participant is on a regimen of psychotropic medication, no changes in this regimen should be made during the period between the time at which...
You likely can't join if
- Diagnosed with acute or chronic psychotic symptoms of disorders (e.g.
- Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or...
- Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or...
- Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.
- Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, as determined by the SCID
- History of seizures
See the full eligibility criteria
- Age 18-70
- Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without psychotic features.
- Has Montgomery-Asberg Depressive Rating Scale (MADRS) of \> 19 at baseline, corresponding with moderate to severe depression.
- Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.
- If participant is on a regimen of psychotropic medication, no changes in this regimen should be made during the period between the time at which pre-treatment and post-treatment scans are taken.
- Willing and able to undergo non-invasive brain stimulation
- Willing and able to attend research visits for approximately 8 weeks
- Willing and able to provide informed consent
- Ability to speak and read English
- Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode.
- Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the...
- Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.
- Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.
- Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, as determined by the SCID
- History of seizures
- Implantable hardware not compatible with MRI or with the study
- Inability to comply with study daily visits
- Women who are pregnant, plan to become pregnant, or breast feeding
- Inability to speak and/or read English
- Inability to give consent
- Any active suicidal intent or plan during the current depressive episode, as determined by a score of 3 on Question #9 of Beck's Depression Inventory (scores reviewed daily by study team members versed in scoring...
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, 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, but 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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.