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Behavioural Intervention
Neurofeedback for Depression
N/A
Recruiting
Led By Deigo Pizzagalli, PhD
Research Sponsored by GrayMatters Health Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal or corrected-to-normal vision and hearing
Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5), with HDRS-21 ≥17 and SHAPS- score ≥25. MDD diagnosis will be determined via the Neuropsychiatric Interview (SCID-V for DSM-5)
Must not have
Current diagnosis of posttraumatic stress disorder (PTSD)
A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Summary
This trial will explore if PRISM neurofeedback can reduce symptoms of depression in those with anhedonia. Participants will complete assessments, MRI scans, and tasks before & after 15 neurofeedback sessions.
Who is the study for?
This trial is for adults aged 22-65 with Major Depressive Disorder (MDD) and Anhedonia, who can complete questionnaires in English and adhere to the study schedule. Participants must have specific scores on depression scales and be right-handed. Exclusions include certain mental health disorders, recent substance abuse, unstable medical conditions, use of excluded medications including benzodiazepines or dopamine-affecting drugs, recent psychotherapy initiation, pregnancy, MRI contraindications like metal implants or claustrophobia.
What is being tested?
The PRISM neurofeedback training study tests if this therapy can reduce symptoms of MDD with Anhedonia when added to standard care. It's a double-blind trial where participants are randomly assigned to receive either active neurofeedback or a sham (placebo) version over approximately two months while undergoing clinical assessments and MRIs before and after the sessions.
What are the potential side effects?
Since this is a non-invasive brain training technique using neurofeedback without medication administration, side effects may be minimal but could potentially include discomfort from wearing an EEG net during sessions or anxiety related to MRI scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vision and hearing are normal, or corrected to be normal.
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I have been diagnosed with major depression and experience a lack of pleasure in most activities.
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I am between 22 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with PTSD.
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I have a history of seizures or am at risk due to head trauma or family history.
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I am not pregnant, nursing, or planning to become pregnant during the trial.
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I am only taking antidepressants at a stable dose.
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I have not used drugs that affect dopamine levels, like bupropion or stimulants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
HDRS-21
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The clinical global impression (CGI-I)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active ArmExperimental Treatment1 Intervention
Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care.
Group II: Control ArmPlacebo Group1 Intervention
Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care.
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Who is running the clinical trial?
GrayMatters Health Ltd.Lead Sponsor
1 Previous Clinical Trials
87 Total Patients Enrolled
Deigo Pizzagalli, PhDPrincipal InvestigatorMclean Hospital
Diego Pizzagalli, PhDPrincipal InvestigatorMclean Hospital
8 Previous Clinical Trials
1,058 Total Patients Enrolled
3 Trials studying Anhedonia
309 Patients Enrolled for Anhedonia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are right-handed according to Chapman and Chapman's method from 1987.My vision and hearing are normal, or corrected to be normal.Your hairstyle makes it difficult to place the EEG net, such as braids, dreadlocks, cornrows, or recently dyed hair.I haven't changed or started any SSRIs or SNRIs in the last 4 weeks and don't plan to change my depression treatment during the study.I cannot stop or switch my Benzodiazepine medication for the study.You have attempted to harm yourself in the past year or have taken steps to do so.I have been diagnosed with major depression and experience a lack of pleasure in most activities.My gender or ethnic background does not limit my participation.I started a recognized therapy for depression within the last 3 months.I have been diagnosed with PTSD.I have a history of seizures or am at risk due to head trauma or family history.My depression fits into a specific type focused on loss of pleasure.I am not pregnant, nursing, or planning to become pregnant during the trial.I am only taking antidepressants at a stable dose.I have not used drugs that affect dopamine levels, like bupropion or stimulants.You have a history of certain mental health conditions like schizophrenia, bipolar disorder, or delusional disorder.You have been diagnosed with a serious problem with drugs or alcohol in the last 3 months.I am between 22 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Active Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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