Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia (NCT06982820) | Clinical Trial Compass
RecruitingNot Applicable
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
United States, Israel170 participantsStarted 2025-06-25
Plain-language 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 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).
Who can participate
Age range22 Years – 75 Years
SexALL
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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.
What they're measuring
1
HDRS-21
Timeframe: Change from baseline to week 12 (post training visit)
. 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.