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Procedure

Depression Group for Major Depressive Disorder

N/A
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Depressed Participants: Moderate to severe depression severity, defined as a 17-item Hamilton Depression Rating Scale260 score ≥ 18
Depressed Participants: Have failed to achieve a clinical response to an adequate dose of an antidepressant based in an Antidepressant Treatment History Form (ATHF) score ≥ 3 in the current episode, or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (AHTF = 1 or 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to end of treatment (up to 8 weeks)
Awards & highlights

Study Summary

This trial aims to help understand how rTMS can improve MDD symptoms by targeting brain activity (via DLPFC) or biomarkers (e.g. proteins) related to reward processing and working memory.

Who is the study for?
This trial is for English-speaking adults aged 18-65 with moderate to severe depression, diagnosed as per specific criteria and who haven't responded well to antidepressants. Participants should not have had medication changes or started psychotherapy recently. Pregnant individuals, those at acute suicide risk, with certain psychiatric or major medical conditions, drug abuse history, or contraindications for rTMS or MRI are excluded.Check my eligibility
What is being tested?
The study tests if stimulating the brain's dorsolateral prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) can improve symptoms of treatment-resistant depression. It involves brain scans before and after treatment to observe changes in DLPFC activity and saliva samples to identify biomarkers related to response.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles, lightheadedness. Serious risks are rare but may include seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My depression is moderate to severe.
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I have depression and haven't responded well to at least two different antidepressants.
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I haven't started or changed the dose of any mental health medication in the last month.
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I have never been diagnosed with a psychiatric condition.
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I have never taken antidepressants.
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I have been diagnosed with Major Depressive Disorder.
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I am between 18 and 65 years old and not suffering from depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to end of treatment (up to 8 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to end of treatment (up to 8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hamilton Rating Scale for Depression

Trial Design

2Treatment groups
Experimental Treatment
Group I: Depression GroupExperimental Treatment4 Interventions
Group II: Control GroupExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,715 Total Patients Enrolled

Frequently Asked Questions

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

Could individuals still enroll in this experiment?

"Clinicaltrials.gov reveals that the recruitment period for this trial is now over, as it was last updated on November 30th 2023. Despite this study no longer being open to candidates, there are 1414 other trials actively recruiting patients at present."

Answered by AI

Is it possible to participate in this research endeavor?

"This clinical trial is seeking 50 individuals suffering from major depression to join with ages ranging between 18 and 65."

Answered by AI

Is the age eligibility for this examination limited to individuals below 45 years?

"This trial necessitates that eligible patients must be aged 18 or above, and not exceed the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Unity Health Toronto
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression
2024. "The Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163625.
~33 spots leftby Dec 2026
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