Using rTMS to treat depression in young adults with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in treating major depressive disorder in transition-aged youth with autism spectrum disorder. The study employs a randomized, double-blind, sham-controlled design, administering bilateral theta burst stimulation to the dorsolateral prefrontal cortex over 30 sessions across six weeks. Participants aged 16-35 without co-occurring intellectual disabilities and with clinically significant depression will be recruited. The trial aims to explore the treatment's efficacy while also utilizing MRI to understand the mechanisms behind treatment responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Fluent in English
* ASD diagnosis confirmed by the clinician/clinical team, and IQ\> or =70
* Able to participate in the informed consent process, provide voluntary informed consent and provide a spontaneous narrative description of the key elements of the study
* Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 30 days; no change in other therapeutic interventions in last 30 days
* BDI-II score ≥21 that is sustained over a lead-in period of two weeks
* Global Assessment of Function (GAF) scores (≤60) that is sustained over a lead-in period of two weeks AND/OR VABS-III below adequate functioning at baseline assessment.

Exclusion Criteria:

* A history of a DSM-5 substance use disorder (other than tobacco) within the past six months; or a positive baseline urine drug screen
* Significantly debilitating medical or neurologic illness, or acute or unstable medical illnesses as determined by study physician
* Metal implants or a pace-maker, claustrophobia that would preclude the MRI scan
* Actively suicidal (i.e., suicidal ideation with plan and intent) or high risk for suicide as assessed by a study psychiatrist
* History of seizures
* Taking benzodiazepines at a dose greater or equal to 2mg Lorazepam or any anticonvulsant medication
* Prior rTMS treatment
* Pregnancy

Where it's running

• Centre for Addiction and Mental Health
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Stephanie H Ameis, MD, MSC — Centre for Addiction and Mental Health
• Study coordinator: Viviane Grassmann, PhD
• Email: AutismTMS@camh.ca
• Phone: 416-535-8501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.