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COMPLETED Phase 4

A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder

NCT00576732 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Risperidone high dose
  • DRUG Risperidone low dose

Study Locations (20)

New York

  • — Manhasset
  • — New York
  • — Staten Island
  • — The Bronx

California

  • — Sacramento
  • — Santa Ana

Florida

  • — Boca Raton
  • — Miami

Illinois

  • — Hoffman Estates
  • — Naperville

Virginia

  • — Fairfax
  • — Portsmouth

Alabama

  • — Dothan

Arizona

  • — Phoenix

Georgia

  • — Smyrna

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2007-12
Est. Completion 2010-03
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00576732

The ClinicalTrials.gov registry entry for NCT00576732 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Autism appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00576732 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00576732 about?

NCT00576732 is a clinical study titled "A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder". 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 h...

What is the current status of trial NCT00576732?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 96 participants. The study started on 2007-12. Estimated completion is 2010-03.

What conditions does trial NCT00576732 study?

This clinical trial studies the following conditions: Autism, Autistic Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00576732?

The interventions under investigation include: Placebo (DRUG), Risperidone high dose (DRUG), Risperidone low dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00576732?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00576732 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial