NCT07439042

Buspirone for Anxiety in Autistic Youth

A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to do a preliminary trial to determine if buspirone is effective, safe, and tolerable in autistic youth with anxiety.

Detailed description

After being informed about the study and potential risks, all patients or their legal guardians giving written informed consent will be screened for study eligibility. Patients who meet the eligibility requirements will participate in a 16-week, flexibly-dosed, randomized controlled trial of buspirone versus placebo. The dose of buspirone will be adjusted over the first 12 weeks of the study and a stable dose will be maintained for the final four weeks of the trial. Adverse effects will be reviewed at each visit and standardized measures of anxiety will be conducted at weeks 4, 8, 12, and 16.

Conditions

• Anxiety
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	buspirone	Buspirone, an anxiety medication that is FDA approved for generalized anxiety disorder in adults, will be the active comparator for this trial.
DRUG	Placebo	Matching placebo capsules/liquid formulation will be prepared.

Timeline

• Start date: 2026-08-01
• Primary completion: 2029-02-01
• Completion: 2029-06-01
• First posted: 2026-02-27
• Last updated: 2026-02-27