Neurofeedback treatment for major depression with anhedonia

A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy

This study is testing a new neurofeedback treatment called Prism to see if it can help people with major depression and a lack of pleasure feel better over 24 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 22 Years to 75 Years
• Sex: All
• Sponsor: GrayMatters Health Ltd. (Industry-sponsored)
• Locations: 3 sites (Providence, Rhode Island and 2 other locations)
• Trial ID: NCT06982820 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate a new treatment called Prism, which utilizes neurofeedback training to help individuals suffering from Major Depressive Disorder (MDD) characterized by anhedonia. Participants will undergo a series of assessments and training sessions over a 24-week period, including brain activity measurements through MRI and EEG. The study will compare the effects of active neurofeedback training against a sham treatment to determine its efficacy in improving depressive symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Major Depressive Disorder and experiencing significant anhedonia, who have previously tried at least one antidepressant treatment.

Not a fit: Patients with contraindications to MRI or those who have exhibited suicidal behavior in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and effective approach for alleviating symptoms of major depression, particularly the loss of pleasure in activities.

How similar studies have performed: While neurofeedback approaches have been explored in other studies, this specific application for MDD with anhedonia is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM5TR) - HDRS-17 score of ≥20, SHAPS-C score of ≥25.
2. Fluency in written and spoken English.
3. Able intellectually to understand the instructions
4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent).
5. Normal or corrected-to-normal vision and hearing.
6. Ability to adhere to the study schedule.
7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.

Exclusion Criteria:

1. Contraindications to MRI (e.g., metal in the body, claustrophobia).
2. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using Columbia -Suicide Severity Rating Scale (C-SSRS) prior to screening and during the screening period.
3. Diagnosis for current moderate or severe substance or alcohol use disorder (SUD/AUD) within the past month (as defined in DSM-5-substance use disorder).
4. Any unstable medical condition, as per the clinical judgement of the investigator.
5. Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs/SNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.
6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.
7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.

Where this trial is running

Providence, Rhode Island and 2 other locations

• Butler Hospital — Providence, Rhode Island, United States (Recruiting)
• Houston Center For Advanced Psychiatric Treatment — Houston, Texas, United States (Recruiting)
• Sheba Medical Center — Ramat Gan, Israel (Recruiting)

Study contacts

• Study coordinator: Adar Shani, MSc

Conditions Depressive Disorder, Major; Major Depressive Disorder; Anhedonia; Depression