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

Launched by GRAYMATTERS HEALTH LTD. · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Prism for people who have Major Depressive Disorder (MDD) and struggle with anhedonia, which means they find it hard to enjoy things they used to like. The goal is to see how well this treatment works by using a special software device that helps train the brain in a clinic. Participants will undergo brain activity measurements using techniques like MRI (a type of scan) and EEG (a test that measures electrical activity in the brain).

To be eligible for this study, participants need to be diagnosed with MDD and have specific scores that indicate their condition. They should also be able to understand the instructions and give permission to participate. However, individuals with certain medical conditions, recent suicidal behavior, or those currently in other treatments may not qualify. If you decide to join, you can expect to engage in the training sessions and participate in the assessments, helping researchers learn more about this innovative approach to treating depression.

Gender

ALL

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.