Tests a brain-training device for depression with loss of pleasure
Tests a brain-training device in adults with depression and loss of pleasure.
Plain-language title generated from the registry record
Registry title: Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Key facts
- Where
- Ramat Gan, IsraelSee the site
Could this be for you?
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?
Source: NCT06982820, who can take part
Where in Israel
- Sheba medical centerRamat Gan, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GrayMatters Health Ltd.
- Trial code
- NCT06982820
- Record updated
- 1 May 2026
- Original description
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
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).
Inclusion: 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.
Exclusion: 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).