No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 55
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
58 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for people with Major Depressive Disorder to test a new brain training technique using MRI. Participants will receive real-time feedback about their brain activity during MRI scans to help manage their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Major Depressive Disorder.
I have a score of 6 or higher on the Patient Health Questionnaire (PHQ9).
If I'm taking antidepressant medications, I've been on a stable dosage for 4 weeks.
I have not had any substance use issues in the past 6 months.
I do not have suicidal thoughts or plans.
If I am a woman of child-bearing age, I am not pregnant or trying to become pregnant.
I can tolerate small, enclosed spaces without anxiety.
I am able and willing to give informed consent.
You may not be able to join if
I do not qualify for the size of the MRI scanner.
I do not have bipolar disorder, schizophrenia, or PTSD.
I have a serious neurological illness or condition affecting my brain function.
I have had a closed head injury with loss of consciousness for more than 5 minutes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to develop a technique called real time fMRI neurofeedback.
This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this stud…
The purpose of this study is to develop a technique called real time fMRI neurofeedback.
This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms.
This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Meets The Diagnostic and Statistical Manual of Mental Disorders five (DSM5) criteria for Major Depressive Disorder, single or recurrent, active or in partial remission
* Patient Health Questionnaire (PHQ9) greater or equal (≥)6, and approximately (\~) 50% with PHQ9≥10
* If par…
Inclusion Criteria:
* Meets The Diagnostic and Statistical Manual of Mental Disorders five (DSM5) criteria for Major Depressive Disorder, single or recurrent, active or in partial remission
* Patient Health Questionnaire (PHQ9) greater or equal (≥)6, and approximately (\~) 50% with PHQ9≥10
* If participants are taking antidepressant medications, on stable dosage for 4 weeks
* No history of active substance use disorder in the past 6 months
* Absence of suicidal thoughts with plans or intentions, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
* If a woman of child-bearing age, not pregnant or trying to become pregnant
* Ability to tolerate small, enclosed spaces without anxiety
* No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (for example metal workers with exposures, protocol has more details), etc.
* Size compatible with scanner gantry (per protocol)
* Ability and willingness to give informed consent to participate.
Exclusion Criteria:
* Size not compatible with scanner
* Not meeting diagnostic criteria for bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder or Post-traumatic stress disorder (PTSD)
* No history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure
* No history of closed head injury, e. g. loss of consciousness \> \~5 min, hospitalization, neurological sequela
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