Using rTMS to treat depression in young adults with autism
A Double-Blind Randomized Controlled Trial Evaluating the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as Treatment for Major Depressive Disorder in Transition-Age Youth With Autism Spectrum Disorder
This study is testing if a new brain stimulation treatment can help young adults with autism and depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04972136 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 16-35 with autism spectrum disorder and clinically significant depression, without co-occurring intellectual disabilities.
Not a fit: Patients with a history of substance use disorders or significant medical or neurological illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing depression in young adults with autism.
How similar studies have performed: Previous studies have shown promising results for rTMS in treating depression in non-autistic populations, but this specific application in autism is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.