Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06982820
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Sponsor:
GrayMatters Health Ltd.
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).
Detailed Description:
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).
Participants will receive 20 NF sessions.
The study will test the following hypothesis:
* H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP
* H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP
Where:
M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants.
\*HDRS-21 is administered for cluster analysis
Participants will receive 20 NF sessions.
The study will test the following hypothesis:
* H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP
* H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP
Where:
M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants.
\*HDRS-21 is administered for cluster analysis
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: