PRISM Neurofeedback Training for MDD Anhedonic Patients
Depression, Anhedonia
About this trial
This is an interventional treatment trial for Depression
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), 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)
Sites / Locations
- McLean HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active Arm
Control Arm
Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care.
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.