RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy

Quick Facts

Study Start:2025-06-01
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06982820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. Fluency in written and spoken English.
  3. 3. Able intellectually to understand the instructions
  4. 4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent).
  5. 5. Normal or corrected-to-normal vision and hearing.
  6. 6. Ability to adhere to the study schedule.
  7. 7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.
  1. 1. Contraindications to MRI (e.g., metal in the body, claustrophobia).
  2. 2. 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.
  3. 3. 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).
  4. 4. Any unstable medical condition, as per the clinical judgement of the investigator.
  5. 5. 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.
  6. 6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.
  7. 7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.

Contacts and Locations

Study Contact

Adar Shani, MSc
CONTACT
+972-54-2347770
adar@graymatters-health.com
Jennifer Yarden, PhD
CONTACT
+972-52-4897823
jennifer@graymatters-health.com

Principal Investigator

Aron Tendler, MD
STUDY_DIRECTOR
GrayMatters Health

Study Locations (Sites)

Novus Psychiatry
Tuscaloosa, Alabama, 35404
United States
Butler Hospital
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: GrayMatters Health Ltd.

  • Aron Tendler, MD, STUDY_DIRECTOR, GrayMatters Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder (MDD)
  • Anhedonia
  • Depression

Additional Relevant MeSH Terms

  • Depressive Disorder, Major