NCT04972136 rTMS for Depression in Young Adults With Autism
| NCT ID | NCT04972136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-01-14 |
| Primary Completion | 2027-01-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-01-14 with a primary completion date of 2027-01-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current clinical trial is focused on evaluating the efficacy of rTMS for treatment of depression in youth and young adults (hereafter called transition aged youth, TAY) with autism spectrum disorder (ASD). The motivation to undertake the current efficacy study is driven by: (1) the substantial impact of depression on TAY with ASD (based on prevalence and contribution to disability/impairment); (2) lack of evidence-based treatments for depression in autism (there are no current trials rigorously evaluating any treatment for depression, i.e., psychotherapeutic, pharmacotherapeutic, brain stimulation); (3) rTMS has demonstrated efficacy in non-autistic individuals to improve symptoms of depression and may be better tolerated in youth than medication treatment; (4) a prior pilot rTMS study focused on treatment of executive function deficits in autism indicated that high frequency rTMS delivered using a rigorous randomized control trial (RCT) protocol can be feasibly implemented in TAY with autism, is well tolerated (mild to moderate adverse effects and low drop out), and has the potential to improve symptoms of depression.
Eligibility 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
Contact & Investigator
Stephanie H Ameis, MD, MSC
PRINCIPAL INVESTIGATOR
Centre for Addiction and Mental Health
Frequently Asked Questions
Who can join the NCT04972136 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04972136 currently recruiting?
Yes, NCT04972136 is actively recruiting participants. Contact the research team at AutismTMS@camh.ca for enrollment information.
Where is the NCT04972136 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04972136 clinical trial?
NCT04972136 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Stephanie H Ameis, MD, MSC at Centre for Addiction and Mental Health. The trial plans to enroll 80 participants.