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.
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
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
University of Michigan
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator