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

April 30, 2026 updated by: GrayMatters Health Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Butler Hospital
        • Principal Investigator:
          • Linda Carpenter, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77401
        • Recruiting
        • Houston Center for Advanced Psychiatric Treatment
        • Principal Investigator:
          • Sandhya Prashad, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active arm
Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC.
Device: Prism Training
Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.
Other Names:
  • Sham Training
Sham Comparator: Sham arm
Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.
Device: Prism Training
Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.
Other Names:
  • Sham Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDRS-21
Time Frame: Change from baseline to week 12 (post training visit)
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Change from baseline to week 12 (post training visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SHAPS-C
Time Frame: Change from baseline to week 12 (post-training visit)
Snaith-Hamilton-Pleasure scale - is a 14- item self-administered measure of anhedonia symptoms.
Change from baseline to week 12 (post-training visit)
HDRS-21
Time Frame: Change from baseline to 3-month FU visit
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Change from baseline to 3-month FU visit
CGI-I
Time Frame: Change from baseline to week 12 (post-training visit)
Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Change from baseline to week 12 (post-training visit)
CGI-I
Time Frame: Change from week 12 to 3-Month follow-up Assessment
Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Change from week 12 to 3-Month follow-up Assessment
PHQ-9
Time Frame: Change from baseline to week 12 (post-Training visit)
Patient Health Questionnaire-9 - The PHQ-9 is a nine-item depressive symptom diagnostic tool.
Change from baseline to week 12 (post-Training visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GrayMatters Health Ltd.

Investigators

  • Study Director: Aron Tendler, MD, GrayMatters Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

April 29, 2025

First Submitted That Met QC Criteria

May 20, 2025

First Posted (Actual)

May 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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