Status:
RECRUITING
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Lead Sponsor:
GrayMatters Health Ltd.
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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 act...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06982820
Start Date
June 25 2025
End Date
August 30 2027
Last Update
October 28 2025
Active Locations (2)
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1
Novus Psychiatry
Tuscaloosa, Alabama, United States, 35404
2
Butler Hospital
Providence, Rhode Island, United States, 02906