Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- GrayMatters Health Ltd.
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- HDRS-21
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.
The main questions it aims to answer are:
- what clinical profile / symptoms-based biomarkers scores can be used by clinics to administer PRISM therapy in conjunction with standard care of therapy?
- What are the initial guidelines for integrating PRISM neurofeedback training for MDD therapy with MDD Anhedonia?
Participants will be randomly assigned to one of two arms, Active, or Sham.
During the study, participants will perform the following:
- Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation.
- Perform at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for 5-8 weeks).
- Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage.
Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
Detailed Description
During the study, participants will perform the following: * Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation. * Perform at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for 5-8 weeks). * Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage. Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ages 22 to 65
- •Any gender and all ethnic/racial origins
- •Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5). MDD diagnosis will be determined via the Structured Clinical Interview for DSM-5 (SCID-V) with ≥17 on the Hamilton Depression Rating Scale (HDRS)-211 and ≥25 on the Snaith-Hamilton Pleasure Scale (SHAPS-C)
- •Fluency in written and spoken English
- •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
- •Exclusion Criteria (All Subjects):
- •Imaging Exclusions
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
HDRS-21
Time Frame: 9 weeks
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Secondary Outcomes
- HDRS-21(3 months)
- The clinical global impression (CGI-I)(9 weeks)
- Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)(3 months)