NCT05869708

PRISM Neurofeedback Training for MDD Anhedonic Patients

Completed NA Last updated 5 September 2025

What this trial tests

NA trial testing Active RS-EFP in Depression in 19 participants. Completed in 3 September 2025.

Timeline

1 July 2023

Primary endpoint
3 September 2025

3 September 2025

Quick facts

Lead sponsor	GrayMatters Health Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	19
Start date	1 July 2023
Primary completion	3 September 2025
Estimated completion	3 September 2025
Sites	1 location across United States

Drugs / interventions tested

• Active RS-EFP
• Sham RS-EFP

Conditions studied

• Depression — all drugs for Depression →
• Anhedonia — all drugs for Anhedonia →

Sponsor

GrayMatters Health Ltd. — full company profile →

Who can join

Adults 22 to 65, any sex, with Depression or Anhedonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.

The goals of this study include:

1. Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample;
2. Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy;
3. Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC).

Participants will be randomly assigned to one of two arms, Active, or Sham.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reward System EEG-fMRI-Pattern Neurofeedback for Major Depressive Disorder with Anhedonia: A Multicenter Pilot Study.
   Amital D, Gross R, Goldental N, Fruchter E, et al · · 2025 · cited 1× · PMID 40426646 · DOI 10.3390/brainsci15050476