NCT04972136Recruiting

rTMS for 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

Source: ClinicalTrials.gov · Last updated 19 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 80 (estimated)
First submitted: 26 May 2021
Start date: 14 Jan 2021
Primary completion date: 14 Jan 2027
Lead sponsor: Centre for Addiction and Mental Health
Diseases: Depression, Autism
NCT number: NCT04972136

What you commit to

Study type: Interventional
Planned participants: 80
From 14 Jan 2021 to the primary completion date, 14 Jan 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Metal implants or a pace-maker, claustrophobia that would preclude the MRI scan
Taking benzodiazepines at a dose greater or equal to 2mg Lorazepam or any anticonvulsant medication
Prior rTMS treatment

Other illness

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
History of seizures

Other

Actively suicidal (i.e., suicidal ideation with plan and intent) or high risk for suicide as assessed by a study psychiatrist
Pregnancy

Who the study is looking for

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.

Age in the registry: 16 years to 35 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Centre for Addiction and Mental Health Coordinator of this site? Confirm its status	Toronto	Canada	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.