Prism Training for Depression

Recruiting at 1 trial location

Overseen By Adar Shani, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GrayMatters Health Ltd.

Must be taking: Antidepressants

Must not be taking: Fluoxetine, SSRIs, SNRIs, Bupropion

Disqualifiers: Suicidal behavior, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

170 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Aron Tendler, MD

Principal Investigator

GrayMatters Health

Eligibility Criteria

This trial is for people with Major Depressive Disorder (MDD) who especially struggle to feel pleasure or interest in things, a condition known as anhedonia. Participants should be able to attend sessions in a clinic and undergo brain activity measurements like MRI and EEG.

Inclusion Criteria

Fluency in written and spoken English

I can understand and follow instructions.

Ability to give signed, informed consent either written or electronic (via REDCap eConsent)

Exclusion Criteria

Contraindications to MRI (e.g., metal in the body, claustrophobia)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment to establish baseline measures before treatment

1 week

1 visit (in-person)

Pre-training

Preparation and initial setup for neurofeedback training

1 week

1 visit (in-person)

Neurofeedback Training

Participants undergo 20 neurofeedback training sessions over 10 weeks

10 weeks

20 visits (in-person)

Booster Training

Additional neurofeedback training sessions to reinforce treatment effects

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Prism

Trial Overview The study is testing Prism, a new software device designed for neurofeedback training aimed at treating MDD with anhedonia. It's used in a clinical setting where patients' brain activities are monitored and trained using advanced techniques.

Participant Groups

Group I: Active arm Active Control 1 Intervention

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.

Group II: Sham arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

GrayMatters Health Ltd.

Lead Sponsor

Trials

4

Recruited

460+