Neurofeedback treatment for major depression with anhedonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: adar@graymatters-health.com
• Phone: +972-54-2347770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brenipatide added to standard care for adults with major depressive disorder

  This study tests whether brenipatide, given alongside standard care, can help delay the return of depressive symptoms in adults with major depressive disorder.

  Recruiting at 47 sites Phase 3 Eli Lilly and Company · Birmingham, Alabama and 169 other locations · NCT07775300

• Student Precarity and Psychiatry: How Financial Struggles Relate to Depression and Loneliness

  This observational study looks at whether financial hardship and social isolation are linked to depression, suicidal thoughts, and loneliness among French university students.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, IDF · NCT07618208

• Seltorexant (JNJ-42847922) as monotherapy for adults and older adults with major depressive disorder

  This trial will test whether seltorexant works better than a placebo to reduce depressive symptoms in adults and elderly people with major depressive disorder.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Bryant, Arkansas and 52 other locations · NCT07573176

• MOCHA: Inpatient Mental Health Care for High-Risk Pregnancy

  This study tests a collaborative mental health program for pregnant or recently postpartum patients hospitalized for medical problems to see if it can be delivered feasibly and acceptably.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07540585

• Brenipatide added to standard antidepressant treatment for adults with major depression

  This trial will see if adding brenipatide to your current antidepressant treatment can delay the return of major depressive symptoms in adults with major depressive disorder.

  Recruiting at 170 sites Phase 3 Eli Lilly and Company · Moorpark, California and 179 other locations · NCT07412756

• Esketamine plus standard care for adolescents with major depressive disorder and acute suicidal thoughts or behavior

  This will test whether adding intranasal esketamine to usual care helps hospitalized adolescents with major depressive disorder and acute suicidal thoughts or behavior feel better faster than a psychoactive placebo plus usual care.

  Recruiting at 49 sites Phase 3 Janssen Research & Development, LLC · Birmingham, Alabama and 48 other locations · NCT07227454

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.