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NCT05869708 | Recruiting | Depression


PRISM Neurofeedback Training for MDD Anhedonic Patients
Sponsor:

GrayMatters Health Ltd.

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 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for about 2 months). 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.

Condition or disease

Depression

Anhedonia

Intervention/treatment

Active RS-EFP

Sham RS-EFP

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025
Arm Intervention/treatment

Experimental: Active Arm

Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care.

Device: Active RS-EFP

Sham Comparator: Control Arm

Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care.

Device: Sham RS-EFP

Ages Eligible for Study: 22 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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), with HDRS-21 ≥17 and SHAPS- score ≥25. MDD diagnosis will be determined via the Neuropsychiatric Interview (SCID-V for DSM-5).
  • Fall within parameters as defined in the Retrospective stage, and/or anhedonic subtype of MDD
  • Right-handed (Chapman and Chapman 1987)
  • 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
  • A history of schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
  • Lifetime diagnosis of autism or intellectual disability at discretion of investigator.
  • Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5-substance use disorder) or at screening visit.
  • Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night at equivalent daily dose of up to 3 mg.
  • Current diagnosis of posttraumatic stress disorder (PTSD).
  • Any psychotropic medication other than a stable dose of antidepressants, e.g., selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs).
  • Because of the focus on RS, any past or current use of DA (Dopamine Agonist)-acting drugs (e.g., bupropion, stimulants, low doses of anti-psychotics used as an augmentation strategy). Also, exclude metformin or any other compound with DA effects.
  • Any change in - or initiation of - SSRIs or SNRIs antidepressants within the past 4 weeks. At the time of recruitment, patients must have no intention of changing their medication or psychotherapy (see also exclusion #10) during the study duration.
  • Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period.
  • Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based MDD psychotherapy (Cognitive Behavior Therapy [CBT], Behavioral Activation Therapy, etc.); continuation of established maintenance supportive therapy will be permitted.
  • A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
  • Any unstable medical condition, as per the clinical judgment of the investigator.
  • Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Contraindications to MRI (e.g., metal in body, claustrophobia).
  • Hairstyles that prevent the application of the EEG net (e.g., braids, dreadlocks, corn rows, recently dyed hair)

PRISM Neurofeedback Training for MDD Anhedonic Patients

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PRISM Neurofeedback Training for MDD Anhedonic Patients

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Massachusetts

McLean Hospital

Belmont, Massachusetts, United States, 02478

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