Recruiting

rTMS for Depression in Young Adults With Autism

ClinicalTrials.gov IDNCT04972136

PhaseNA

Enrollment80

SponsorCentre for Addiction and Mental Health

Age16 Years – 35 Years

SexALL

I'm interested View official listing

Conditions studied

Autism Spectrum Disorder, Major Depressive Disorder

About this study

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.

Interventions

Device: Active Bilateral Theta Burst Stimulation — A total of 30 active BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
Device: Sham Bilateral Theta Burst Stimulation — A total of 30 sham BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)

Primary outcomes

Change in scores on the 17-item Hamilton Rating Scale for Depression (HRSD-17) (Baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.)

Eligibility information

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

Study locations

Centre for Addiction and Mental Health, Toronto, Ontario M6J 1H4 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.