Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Depressive Disorder, Major
In brief
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).
Key facts
- Study ID
- NCT06982820
- Run by
- GrayMatters Health Ltd.
- People needed
- 170
- Starts
- 2025-06-25
- Expected to finish
- 2027-08-30
- Last updated by the study team
- 2026-05-01
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Contraindications to MRI (e.g., metal in the body, claustrophobia).
- 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.
- 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.
- 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.
Where it is running
- Butler Hospital — Providence, Rhode Island, United States (enrolling)
- Houston Center For Advanced Psychiatric Treatment — Houston, Texas, United States (enrolling)
- Sheba Medical Center — Ramat Gan, Israel (enrolling)
Full record on ClinicalTrials.gov
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