PRISM Neurofeedback Training for MDD Anhedonic Patients

NCT05869708 | Completed FDA Device

• 1 other identifier: CLP011
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 goals of this study include:

1. 1.Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample;
2. 2.Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy;
3. 3.Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC).

Conditions

Depression; Anhedonia

Outcome Measures

Primary Outcomes (1)

• HDRS-21

  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.

  9 weeks

Secondary Outcomes (4)

• Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)

  9 weeks

• HDRS-21

  3 months

• Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)

  3 months

• The clinical global impression (CGI-I)

  9 weeks

Study Arms (2)

Active Arm

EXPERIMENTAL

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

Device: Active RS-EFP

Control Arm

SHAM COMPARATOR

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

Interventions

Active RS-EFP DEVICE

A minimum of 10 and up to 15 active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session.

Active Arm

Sham RS-EFP DEVICE

a minimum of 10 and up to 15 sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session.

Control Arm

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A history of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, organic mental disorder, severe borderline or antisocial personality disorder, current bulimia nervosa2, current binge eating disorder2, or current anorexia nervosa3.
• Lifetime Diagnosis of autism or intellectual disability at the discretion of the investigator.
• Current primary diagnosis of posttraumatic stress disorder (PTSD), specific phobia, panic disorder, social anxiety disorder, obsessive compulsive disorder, or generalized anxiety disorder; subjects with MDD as a primary diagnosis may be included.
• First-degree relatives with a history of psychotic disorder or psychotic symptoms outside of the context of a mood disorder (i.e., MDD or bipolar disorder)
• 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.
• Any current drug use as assessed by a positive result on urine drug test (covering cocaine, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)
• Allow positive result for cannabinoids if participant verbally confirms they have not used MJ in past 12 hours prior to study visit
• Use of any antibiotics in the 24 hours prior to an MRI scan procedure
• \. Any unstable medical condition, as per the clinical judgement of the investigator.
• \. 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 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.
• History of ECT, TMS, or Ketamine in the current Major Depressive Episode (allowable in previous MDEs)
• Completion of two full courses of other therapies within the current episode
• Any psychotropic medication other than a stable dose of antidepressants, e.g., bupropion, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitor (SNRIs), St. John's Wort, or SAMe.
• Any change in - or initiation of - fluoxetine within the past 8 weeks or other SSRIs or SNRIs antidepressants, bupropion, simulants, or other psychiatric medications within the past 4 weeks. At the time of recruitment, patients must have no intention of changing their medication or psychotherapy during the study duration.

Sponsors & Collaborators

• GrayMatters Health Ltd.: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depression; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diego Pizzagalli, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 22, 2023
• Study Start: July 1, 2023
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)