rTMS for Major Depressive Disorder

N/A

Recruiting

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)

Must not have

All Participants: Other major medical comorbidities requiring immediate investigation or treatment, cardiac pacemaker, or implanted medication pump

All Participants: Lifetime history of psychosis, including schizophrenia, schizoaffective disorder, delusional disorder, or current psychotic symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I do not have major health issues needing immediate treatment, a pacemaker, or an implanted medication pump.

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I have never had psychosis, schizophrenia, schizoaffective disorder, or delusional disorder.

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I have not had ECT for my current depressive episode.

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I do not have major brain or neurological conditions.

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I don't have a history of seizures, cochlear implants, use high doses of benzodiazepines, have a cardiac pacemaker or neurostimulator, or had significant head trauma.