NCT06050070 Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
| NCT ID | NCT06050070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2024-03-18 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2024-03-18 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Stephan Taylor, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06050070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06050070 currently recruiting?
Yes, NCT06050070 is actively recruiting participants. Contact the research team at shovakim@med.umich.edu for enrollment information.
Where is the NCT06050070 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06050070 clinical trial?
NCT06050070 is sponsored by University of Michigan. The principal investigator is Stephan Taylor, MD at University of Michigan. The trial plans to enroll 58 participants.