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New treatment option for Autism Spectrum Disorder
Official title rTMS for Depression in Young Adults With Autism
ClinicalTrials.gov ID: NCT04972136
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 35
You may be able to join if
- 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...
- Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 30 days; no change in other...
- BDI-II score ≥21 that is sustained over a lead-in period of two weeks
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.