NCT04807517

Buspirone Treatment of Anxiety in Williams Syndrome

Buspirone for the Treatment of Anxiety in Williams Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to do a preliminary assessment of whether buspirone is effective, safe, and tolerable in the treatment of anxiety in children, adolescents, and adults with Williams syndrome.

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, open-label trial of buspirone. 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

• Williams Syndrome
• Anxiety

Interventions

Type	Name	Description
DRUG	Buspirone	All participants in the study will receive open-label treatment with orally administered buspirone for the full duration of the 16-week trial. Buspirone has high affinity for serotonin 5-HT1A and 5-HT2 receptors and moderate affinity for dopamine D2 receptors. It is approved for the management of generalized anxiety disorder in adults.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2021-03-19
• Last updated: 2024-12-03
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study