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Completed Phase 2Phase 3 Interventional

Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder

ClinicalTrials.gov ID: NCT00873509

Public ClinicalTrials.gov record NCT00873509. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 12:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Placebo-controlled, Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.

Study identification

NCT ID
NCT00873509
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Chugani, Diane C.
Individual
Enrollment
166 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2009
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014
Last update posted
Jul 25, 2016

2009 – 2015

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
University California Davis M.I.N.D. Institute Sacramento California 95817
Children's Hospital of Michigan Wayne State University Detroit Michigan 48201
New York University Langone Medical Center New York New York 10016
Rainbow Babies and Children's Hospital Cleveland Ohio 44106
Cleveland Clinic Lerner College of Medicine Cleveland Ohio 44195
University of Texas Southwestern Dallas Texas 75390

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00873509, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 25, 2016 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00873509 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →