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Taking people in IsraelNo phase

Tests a brain-training device for depression with loss of pleasure

Tests a brain-training device in adults with depression and loss of pleasure.

Key facts

Who runs it
GrayMatters Health Ltd.
Where
Ramat Gan, IsraelSee the siteAlso in 1 other country, 2 sites
Trial code
Registry title
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Status
Recruiting
People taking part
170 people, planned
Started
25 Jun 2025
Expected to end
30 Aug 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Prism Training
Record updated
1 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depression who have lost pleasure or interest in activities and have already tried at least one antidepressant course. It tests Prism, a brain training software used in a clinic.

Age
22 Years to 75 Years
Sex
All sexes can join.
Disease stage
Major depressive disorder with anhedonia (loss of pleasure or interest). HDRS-17 score of 20 or more and SHAPS-C score of 25 or more.
Earlier treatment
Must have completed at least one antidepressant treatment course at an adequate dose and length in the current episode. No change in or start of fluoxetine in the past 8 weeks. No change in or start of other SSRIs/SNRIs, bupropion, stimulants or other psychiatric medicines in the past 4 weeks. No new psychotherapy in the past 2 months.

Main reasons for not taking part

  • Cannot have an MRI (for example metal in the body or claustrophobia)
  • Any suicidal behavior in the past 1 year
  • Current moderate or severe substance or alcohol use disorder in the past month
  • Any unstable medical condition
  • Enrolled in another treatment study now or in the past 2 months

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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
  • Fluency in written and spoken English
  • Able intellectually to understand the instructions
  • Ability to give signed, informed consent either written or electronic (via REDCap eConsent)
  • Normal or corrected-to-normal vision and hearing
  • Ability to adhere to the study schedule
  • Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ

Who cannot take part

  • 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
  • Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted
  • Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study
  • 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)
  • Any unstable medical condition, as per the clinical judgement of the investigator
  • 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
  • Contraindications to MRI (e.g., metal in the body, claustrophobia)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 22 and 75 years old?

Where in Israel

Also in 1 other country, 2 sites

  • Sheba medical centerRamat Gan, IsraelContact: Sharon Baltansky, B.A.Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Active armExisting treatment, for comparison

    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.

    Treatment: Prism Training

  • Sham armSham treatment, for comparison

    Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.

    Treatment: Prism Training

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests a brain-training device for depression with loss of pleasureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06982820, who can take part
Record updated
1 May 2026