Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
- Conditions
- Depressive Disorder, Major
- Registration Number
- NCT06982820
- Lead Sponsor
- GrayMatters Health Ltd.
- 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 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).
- 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 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HDRS-21 Change from baseline to week 12 (post training visit) Hamilton Rating Scale for Depression
- Secondary Outcome Measures
Name Time Method SHAPS-C Change from baseline to week 12 (post-training visit) Snaith-Hamilton-Pleasure scale
HDRS-21 Change from baseline to 3-month FU visit Hamilton Rating Scale for Depression
CGI-I Change from week 12 to 3-Month follow-up Assessment Clinical global impression
PHQ-9 Change from baseline to week 12 (post-Training visit) Patient Health Questionnaire-9
Trial Locations
- Locations (2)
Novus Psychiatry
🇺🇸Tuscaloosa, Alabama, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States