Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Major Depressive Disorder
About this trial
This is an interventional basic science trial for Major Depressive Disorder focused on measuring Functional MRI, Neurofeedback
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 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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Sham controlled feedback
Real-time neurofeedback
Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.
Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.