Neurofeedback training for improving depression

Confirmatory Efficacy Randomized Clinical Trial of Amygdala Neurofeedback for Major Depressive Disorder

This study is testing whether a new type of brain training can help people with major depression feel better by improving their response to positive memories.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05703256 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of real-time fMRI neurofeedback (rtfMRI-nf) aimed at enhancing the amygdala's response to positive memories as a treatment for major depressive disorder (MDD). Over four years, 200 participants from the Pittsburgh area will be randomly assigned to receive either amygdala neurofeedback or sham feedback during two sessions. The study will assess changes in depression severity through clinician-administered and self-report measures over a year following the intervention. The goal is to confirm the therapeutic potential of this innovative approach for treating MDD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with a primary diagnosis of major depressive disorder who are currently experiencing depressive symptoms.

Not a fit: Patients with unstable medical conditions, severe substance use disorders, or those unable to undergo MRI scans will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a novel, non-pharmacological treatment option for patients suffering from major depressive disorder.

How similar studies have performed: Previous studies have shown promising results with rtfMRI-nf approaches for depression, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* ages 18 - 55
* primary diagnosis of MDD and are currently depressed
* able to give written informed consent prior to participation
* unmedicated OR are stable on an antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.

Exclusion Criteria:

* clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
* Current severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention.
* history of traumatic brain injury
* unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
* currently pregnant or breast feeding
* unable to complete questionnaires written in English
* current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study.
* diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
* eye problems or difficulties in corrected vision.

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Kymberly Young, PhD — University of Pittsburgh
• Study coordinator: Kymberly Young, PhD

Conditions: Major Depressive Disorder, neurofeedback, amygdala, depression, major depressive disorder