NCT03432065

A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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 trial with explicit hypotheses and sufficient statistical power.

Conditions

• Autism Spectrum Disorder
• Anxiety

Interventions

Type	Name	Description
DRUG	Buspirone	Children with autism spectrum disorders will receive buspirone treatment for eight weeks. 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 until the end of the trial. During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2018-02-13
• Last updated: 2024-09-26

Regulatory

• FDA-regulated drug study