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Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia

GrayMatters Health Ltd. · NCT06982820

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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
All mental health studies in Rhode Island →
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD)… (NCT06982820) | Bored Studies