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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 20 visits, 2 visits
  • Time periods mentioned: 10 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG)."
  • "The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion 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. Exclusion Criteria: 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.

Study sites (2)

RI

TX