← Back to Search

Procedure

Virtual Reality + rTMS for Depression

N/A

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female or male patients between ages 18-65

Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5)

Must not have

Active neurologic disease

Taking more than 2 mg lorazepam (or an equivalent) or any anticonvulsant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks after treatment

Summary

This trial is investigating a potential new treatment for anhedonia, which is a symptom of major depressive disorder. Previous studies have shown that anhedonia in depression is associated with changes in brain activity and

Who is the study for?

This trial is for adults aged 18-65 with major depressive disorder and significant anhedonia, who have been on a stable antidepressant regimen for at least four weeks. Participants must not have psychosis, mania, active neurological disease, seizure history, recent substance abuse (except caffeine/nicotine), acute suicidal thoughts or certain personality disorders.

What is being tested?

The study tests whether virtual reality reward training can enhance the effects of repetitive transcranial magnetic stimulation (rTMS) in treating depression-related anhedonia. It explores if this combination improves mood by activating specific brain circuits associated with pleasure and reward.

What are the potential side effects?

Potential side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. Virtual reality might cause motion sickness or temporary disorientation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I have been diagnosed with major depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an active neurological condition.

Select...

I take more than 2 mg of lorazepam or its equivalent, or I am on anticonvulsant medication.

Select...

I have undergone rTMS treatment before.

Select...

I did not improve after 8 or more electroconvulsive therapy sessions.

Select...

I have used or am using ketamine for major depression.

Select...

I have had seizures at some point in my life.

Select...

I am currently having thoughts about harming myself.

Select...

I have had or currently have psychosis or mania.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Hamilton Depression Rating Scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Virtual reality + rTMSExperimental Treatment2 Interventions

Each treatment session involves: 12-15 min VR viewing, 15 min descriptive and imaginal recounting followed immediately by 3 min rTMS delivery with iTBS to the left DLPFC.

Group II: Virtual reality sham + rTMSPlacebo Group2 Interventions

Each treatment session involves: 12-15 min VR viewing, 15 min descriptive and imaginal recounting followed immediately by 3 min rTMS delivery with iTBS to the left DLPFC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 10Eligibility criteria met