Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia

Last updated: April 30, 2026
Sponsor: GrayMatters Health Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Prism Training

Clinical Study ID

NCT06982820
CLP015
  • Ages 22-75
  • All Genders

Study Summary

The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting.

During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic andStatistical 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 REDCapeConsent).

  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 andduration in the current episode per the ATRQ.

Exclusion

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 -SuicideSeverity 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 otherSSRIs/SNRIs antidepressants, bupropion, stimulants, or other psychiatric medicationswithin the past 4 weeks.

  6. Recent initiation (within the past 2 months) of psychotherapy; continuation ofestablished maintenance supportive therapy will be permitted.

  7. Enrollment in another therapeutic clinical study at screening or within 2 monthsprior to screening or intended enrollment within the duration of this study.

Study Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: Prism Training
Phase:
Study Start date:
June 25, 2025
Estimated Completion Date:
August 30, 2027

Study Description

The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24).

Participants will receive 20 NF sessions.

The study will test the following hypothesis:

  • H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP

  • H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP

Where:

M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants.

*HDRS-21 is administered for cluster analysis

Connect with a study center

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan 293788,
    Israel

    Site Not Available

  • Novus Psychiatry

    Tuscaloosa, Alabama 35404
    United States

    Site Not Available

  • Novus Psychiatry

    Tuscaloosa 4094455, Alabama 4829764 35404
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Butler Hospital

    Providence 5224151, Rhode Island 5224323 02906
    United States

    Site Not Available

  • Houston Center For Advanced Psychiatric Treatment

    Houston, Texas 77401
    United States

    Active - Recruiting

  • Houston Center For Advanced Psychiatric Treatment

    Houston 4699066, Texas 4736286 77401
    United States

    Site Not Available

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