Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
NCT06982820

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

Led by GrayMatters Health Ltd. · Updated on 2026-05-01

170

Participants Needed

3

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 22Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary diagnosis of Major Depressive Disorder with anhedonia per DSM5TR with HDRS-17 score ≥ 20 and SHAPS-C score ≥ 25
  • Fluent in written and spoken English
  • Able to understand study instructions
  • Able to give signed informed consent (written or electronic)
  • Normal or corrected vision and hearing
  • Able to follow the study schedule
  • Completed at least one antidepressant treatment course at adequate dose and duration in current episode
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as metal in body or claustrophobia
  • Suicidal behavior within past year (attempts or preparatory acts)
  • Moderate or severe substance or alcohol use disorder in past month
  • Any unstable medical condition
  • Change or start of fluoxetine within past 8 weeks or other antidepressants within past 4 weeks
  • Psychotherapy started within past 2 months (maintenance therapy allowed)
  • Participation in another therapeutic clinical study at screening or within 2 months prior

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Butler Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

2

Houston Center For Advanced Psychiatric Treatment

Houston, Texas, United States, 77401

Actively Recruiting

3

Sheba Medical Center

Ramat Gan, Israel

Actively Recruiting

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Research Team

A

Adar Shani, MSc

CONTACT

J

Jennifer Yarden, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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