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
Centre for Addiction and Mental Health
80 participants
Jan 14, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
A total of 30 active BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
A total of 30 sham BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04972136