rTMS for Depression in Young Adults With Autism
Recruiting · NCT04972136 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre for Addiction and Mental Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Centre for Addiction and Mental Health - Toronto, Ontario, Canada