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

NCT06982820 · GrayMatters Health Ltd.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24). Participants will receive 20 NF sessions. The study will test the following hypothesis: * H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP * H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP Where: M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants. \*HDRS-21 is administered for cluster analysis
Eligibility criteria
Inclusion Criteria: 1. 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. 2. Fluency in written and spoken English. 3. Able intellectually to understand the instructions 4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent). 5. Normal or corrected-to-normal vision and hearing. 6. Ability to adhere to the study schedule. 7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ. Exclusion Criteria: 1. Contraindications to MRI (e.g., metal in the body, claustrophobia). 2. 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. 3. 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). 4. Any unstable medical condition, as per the clinical judgement of the investigator. 5. 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. 6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted. 7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
Study design
Enrollment target: 170 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-06-25
Estimated completion: 2027-08-30
Last updated: 2026-03-04
Interventions
Device: Prism Training
Primary outcomes
  • HDRS-21 (Change from baseline to week 12 (post training visit))
Sponsor
GrayMatters Health Ltd. · industry
Contacts & investigators
ContactAdar Shani, MSc · contact · adar@graymatters-health.com · +972-54-2347770
ContactJennifer Yarden, PhD · contact · jennifer@graymatters-health.com · +972-52-4897823
InvestigatorAron Tendler, MD · study_director, GrayMatters Health
All locations (3)
Butler HospitalRecruiting
Providence, Rhode Island, United States
Houston Center For Advanced Psychiatric TreatmentRecruiting
Houston, Texas, United States
Sheba Medical CenterNot Yet Recruiting
Ramat Gan, Israel
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia · TrialPath