Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
GrayMatters Health Ltd. · NCT06982820
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 170
- US sites recruiting
- 2
- Study start
- June 25, 2025
- Record last updated
- May 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Prism Training
Conditions: Depressive Disorder, Major
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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.
Recruiting US locations
Butler Hospital
Providence, RI 02906
Site contact: Eric Tirrell · 401-455-6633 · ETirrell@Butler.org
Houston Center For Advanced Psychiatric Treatment
Houston, TX 77401
Site contact: Sarah Hartigan · 832-730-5196 · sarah@sprashadmd.com
Study contacts (from the official record)
- Adar Shani, MSc · +972-54-2347770 · adar@graymatters-health.com
- Jennifer Yarden, PhD · +972-52-4897823 · jennifer@graymatters-health.com
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