PRISM Neurofeedback Training for MDD Anhedonic Patients

Depression Clinical Trial

Official title: Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes

Status Recruiting

Clinical Trial Summary

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 main questions it aims to answer are:

1. what clinical profile / symptoms-based biomarkers scores can be used by clinics to administer PRISM therapy in conjunction with standard care of therapy?

2. What are the initial guidelines for integrating PRISM neurofeedback training for MDD therapy with MDD Anhedonia?

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

During the study, participants will perform the following:

• Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation.

• Perform 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for about 2 months).

• Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage.

Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anhedonia
• Depression

• NCT number: NCT05869708
• Study type: Interventional
• Source: GrayMatters Health Ltd.
• Contact: Liora Levi, PhD
• Phone: +972509260334
• Email: liora@graymatters.health
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: May 1, 2025