A Phase 2 interventional study of Buspirone and Placebo in Autism Spectrum Disorder (ASD), sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
The main objective of this exploratory 8 week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
Browse Autism Spectrum Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Drug: Buspirone
Drug: Placebo
Children with Autism Spectrum Disorders will receive buspirone or matched placebo. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards subjects will be maintained on maximum achieved dose till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.
Also known as: Buspar
Children with Autism Spectrum Disorders will receive buspirone or matched placebo. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards subjects will be maintained on maximum achieved dose till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.
Reduction in Pediatric Anxiety Rating Scale (PARS) Score
Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by change from baseline. Responders are defined as ≥30% reduction in the Pediatric Anxiety Rating Scale (PARS).
Time frame: baseline to 8 weeks
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score
Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by Clinical Global Impression-Anxiety (CGI-Anxiety). Responders are defined as a score of ≤2 on the improvement subscale (i.e., "much" or "very much improved").
Time frame: baseline to 8 weeks
This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buspirone
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