CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Buspironedrug
Likely dose
Buspirone 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01850355
NCT01850355N/ACompleted

An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Massachusetts General Hospital·interventional·Posted May 9, 2013·Updated Feb 25, 2025

In Brief

A clinical study evaluating Buspirone for Autism Spectrum Disorders and Anxiety. Completed, enrolled 9 participants across 1 site.

Detailed 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 hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2013
Enrollment StartJul 1, 2013
Primary CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 13.1 years ago

Interventions

Buspironedrug

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 (dose maintenance pahe). During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.