NCT06982820Recruiting
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) 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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 25 Jun 2025
- Primary completion date
- 30 May 2027
- Lead sponsor
- GrayMatters Health Ltd.
- Diseases
- Depression
- NCT number
- NCT06982820
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 25 Jun 2025 to the primary completion date, 30 May 2027
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Contraindications to MRI (e.g., metal in the body, claustrophobia).
Who the study is looking for
- 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.
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Houston Center For Advanced Psychiatric Treatment Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Butler Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.