RecruitingNot ApplicableNCT04972136

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


Sponsor

Centre for Addiction and Mental Health

Enrollment

80 participants

Start Date

Jan 14, 2021

Study Type

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

Min Age: 16 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether repetitive Transcranial Magnetic Stimulation (rTMS) — a non-invasive brain stimulation technique — can help treat moderate-to-severe depression in young adults who also have autism spectrum disorder (ASD). **You may be eligible if...** - You have a confirmed ASD diagnosis and an IQ of 70 or above - You speak English fluently - You are able to provide informed consent - You have not changed psychiatric medications or other therapeutic interventions in the last 30 days - Your depression score (BDI-II) is 21 or above, confirmed over a two-week lead-in period - Your overall functioning is significantly impaired, as measured by standard scales **You may NOT be eligible if...** - You have a current substance use disorder - You have a condition or history that makes TMS unsafe (such as a metal implant in the head, history of seizures, or certain heart devices) - You have had recent changes to your medications - You do not meet the minimum depression severity threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive Bilateral Theta Burst Stimulation

A total of 30 active BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)

DEVICESham Bilateral Theta Burst Stimulation

A total of 30 sham BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04972136


Related Trials