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Behavioural Intervention

Rapid Acting TMS for Depression and Suicide Ideation

N/A

Recruiting

Led By David Spiegel, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder II (BAPD II), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).

Age 22-65 year old at the time of screening on voluntary or involuntary hold

Must not have

History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)

No access to clinical rTMS after discharge.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Summary

This trial found that aiTBS may reduce explicit and implicit suicidal cognition in people with MDD.

Who is the study for?

This trial is for adults aged 22-65 with major depressive disorder or bipolar II, experiencing suicidal thoughts. They must be TMS naive, in good health, and agree to use contraception if applicable. Excluded are those with certain mental disorders, substance abuse issues, metal implants or shrapnel in the head, seizures history, severe insomnia or who are pregnant.

What is being tested?

The study tests accelerated intermittent theta-burst stimulation (aiTBS) against a sham treatment to see its effect on brain networks related to suicidal thinking in depressed patients. Participants will receive either real aiTBS or a placebo-like version without active stimulation.

What are the potential side effects?

While not explicitly listed here, typical side effects of TMS may include headache, scalp discomfort at the site of stimulation, lightheadedness and rare risk of seizure. Other potential risks should be discussed with the research team.

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 Depressive Disorder or Bipolar II.

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I am between 22 and 65 years old.

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I haven't used ketamine for my current depressive episode.

Exclusion Criteria

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

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I have a history of epilepsy or seizures.

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I won't have access to rTMS treatment after leaving the hospital.

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My IQ is below 70.

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I am experiencing withdrawal symptoms from alcohol or benzodiazepines.

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My treatment's intensity is more than 65% of the maximum level.

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I have been diagnosed with obsessive-compulsive disorder.

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I have undergone TMS therapy before.

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I am currently experiencing mania or psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day 0) and at post-inpatient treatment completion (day 2-7) for reporting.