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Transcranial Magnetic Stimulation

rTMS + Cognitive Therapy for Depression

N/A

Recruiting

Led By Sarah H Lisanby, M.D.

Research Sponsored by National Institute of Mental Health (NIMH)

Eligibility Criteria Checklist

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

Must have

Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria -- HAM-D score greater than 17 and Item 1 score greater than or equal to 2. Alternatively: At the initial screening and beginning of Phase II, subjects must have a baseline score on the MADRS greater than or equal to 20 and YMRS of less than 12.

HAM-D score > 17 and Item 1 score greater than or equal to 2. Alternatively: At the initial screening and beginning of Phase II, subjects must have a baseline score on the MADRS >= 20 and YMRS of < 12

Must not have

Subjects who have hearing loss that has been clinically evaluated and diagnosed

Lifetime history of TMS treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after initiating intervention

Summary

This trial is testing whether combining MRI-guided transcranial magnetic stimulation (TMS) with talk therapy can help treat depression by finding the best area for TMS stimulation in each person and making the therapy more effective.

Who is the study for?

Adults aged 18-75 with major depressive disorder, who have not responded to at least one antidepressant or ECT (unless within the last year), and are on a stable medication dose for four weeks. Participants must understand the study, consent to it, commit to an intensive treatment schedule, use birth control if applicable, and have a depression severity score above set thresholds.

What is being tested?

The trial is testing whether combining MRI-guided transcranial magnetic stimulation (TMS) with cognitive therapy improves depression symptoms more effectively than sham TMS plus cognitive therapy. It includes initial evaluations followed by six weeks of daily sessions and subsequent follow-ups over three months.

What are the potential side effects?

Possible side effects include discomfort from wearing headgear during brain activity tests, reactions to electrical nerve stimulation like tingling or twitching, headaches from TMS sessions, and general unease in confined spaces due to MRI scans.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with major depression and my depression is severe.

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My depression is severe, and I'm not highly manic.

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I have been diagnosed with Major Depressive Disorder.

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I am between 18 and 75 years old.

Exclusion Criteria

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

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I have been diagnosed with hearing loss by a doctor.

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I have received TMS treatment in the past.

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I am not planning to start any new treatments, including therapy or antidepressants, during Phases I and II of the study.

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I have a serious or unstable health condition.

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I have tested positive for COVID-19 or have symptoms of it.

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I have experienced ringing in my ears.

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My depression is caused by another health issue or by substance use.

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I have never been diagnosed with bipolar, psychotic disorders, or major depression with psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ variable: some 6 weeks after initiating intervention; others weekly

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~variable: some 6 weeks after initiating intervention; others weekly

This trial's timeline: 3 weeks for screening, Varies for treatment, and variable: some 6 weeks after initiating intervention; others weekly for reporting.