A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder
Public ClinicalTrials.gov record NCT00576732. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children or adolescents who have autism, and to evaluate the safety and tolerability of the drug for additional 26 weeks after the initial 6-week study period.
Study identification
- NCT ID
- NCT00576732
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 96 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 17 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
- Dec 2007 (Type not available)
- Primary completion
- Sep 2009 (Actual)
- Completion
- Mar 2010 (Actual)
- Last update posted
- May 9, 2014
2007 – 2010
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Dothan | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Santa Ana | California | — | — |
| Not listed | Boca Raton | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Smyrna | Georgia | — | — |
| Not listed | Hoffman Estates | Illinois | — | — |
| Not listed | Naperville | Illinois | — | — |
| Not listed | Lake Charles | Louisiana | — | — |
| Not listed | Manhasset | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Staten Island | New York | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Fairfax | Virginia | — | — |
| Not listed | Portsmouth | Virginia | — | — |
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 NCT00576732, 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 May 9, 2014 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00576732 live on ClinicalTrials.gov.