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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks after treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am between 18 and 65 years old.

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I have been diagnosed with major depression.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,274 Total Patients Enrolled

36 Trials studying Depression

9,526 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The initial posting of the trial was made on October 29th, 2021 and it has been recently updated as of December 20th, 2023. This study aims to recruit a total of 34 individuals from one designated site."

Answered by AI

Does this research study have an age restriction that excludes individuals under the age of 40?

"To be eligible for enrollment in this study, participants must meet the age requirements of being at least 18 years old and not exceeding 65 years of age."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, the data available on clinicaltrials.gov indicates that this trial is presently in the recruitment phase. The initial posting of the trial was on October 29th, 2021, and it underwent its most recent revision on December 20th, 2023. For this study, researchers aim to enroll a total of 34 patients at a single site."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for involvement in this medical study?

"To be eligible for participation in this research study, individuals must have a diagnosis of depression and fall within the age range of 18 to 65 years. A total of 34 participants will be enrolled in this clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression

Dr. Peter Giacobbe 2021. "Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06178731.

All > Transcranial Magnetic Stimulation