Status:
RECRUITING
Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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 acti...
Detailed Description
Part 3/Phase 3 study hypothesis are: * Rest Focus Task (RFT) will activate brain networks at the individual subject level to provide a viable signal for Neurofeedback (NF) * At the group level, RFT i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06050070
Start Date
March 18 2024
End Date
September 1 2026
Last Update
October 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109