Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia

NCT06982820 | Recruiting DMC FDA Device

• 1 other identifier: CLP015
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 3

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).

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder (MDD); Anhedonia; Depression

Outcome Measures

Primary Outcomes (1)

• HDRS-21

  Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.

  Change from baseline to week 12 (post training visit)

Secondary Outcomes (5)

• SHAPS-C

  Change from baseline to week 12 (post-training visit)

• HDRS-21

  Change from baseline to 3-month FU visit

• CGI-I

  Change from baseline to week 12 (post-training visit)

• CGI-I

  Change from week 12 to 3-Month follow-up Assessment

• PHQ-9

  Change from baseline to week 12 (post-Training visit)

Study Arms (2)

Active arm

ACTIVE COMPARATOR

Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC.

Device: Prism Training

Sham arm

SHAM COMPARATOR

Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.

Device: Prism Training

Interventions

Prism Training DEVICE

Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.

Also known as: Sham Training

Active arm; Sham arm

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GrayMatters Health Ltd.: lead

Study Sites (3)

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Houston Center For Advanced Psychiatric Treatment

Houston, Texas, 77401, United States

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Anhedonia; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Aron Tendler, MD

  GrayMatters Health

  STUDY DIRECTOR

Central Study Contacts

Adar Shani, MSc

CONTACT

+972-54-2347770; adar@graymatters-health.com

Jennifer Yarden, PhD

CONTACT

+972-52-4897823; jennifer@graymatters-health.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind: neither participants nor clinicians assessing them will have information regarding the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, double-blind, controlled study

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 21, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-03

Locations

US (2); IL (1)