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

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).

Conditions

Depressive Disorder, Major
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Related Conditions:

Depressive Disorder, Major

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Depressive Disorder, Major
Intervention / Treatment

-

Contacts and Locations

Tuscaloosa

Novus Psychiatry, Tuscaloosa, Alabama, United States, 35404

Providence

Butler Hospital, Providence, Rhode Island, United States, 02906

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. Fluency in written and spoken English.
  • 3. Able intellectually to understand the instructions
  • 4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent).
  • 5. Normal or corrected-to-normal vision and hearing.
  • 6. Ability to adhere to the study schedule.
  • 7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.
  • 1. Contraindications to MRI (e.g., metal in the body, claustrophobia).
  • 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. 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. Any unstable medical condition, as per the clinical judgement of the investigator.
  • 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. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.
  • 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.

Ages Eligible for Study

22 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GrayMatters Health Ltd.,

Aron Tendler, MD, STUDY_DIRECTOR, GrayMatters Health

Study Record Dates

2027-08-30