Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

NCT00166595 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in children in relation to side effects and clinical response to risperidone.

Interventions

  • DRUG Risperidone

Study Locations (4)

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • The Ohio State University Medical Center — Columbus

Michigan

  • Children's Hospital of Michigan/Wayne State University — Detroit

North Carolina

  • Duke University Medical Center — Durham

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2003-02
Est. Completion 2005-03
Phase Phase 1

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00166595

The ClinicalTrials.gov registry entry for NCT00166595 describes a study currently listed as completed. It is categorized as Phase 1, 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 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Child Development Disorders, Pervasive appearing as the primary indexed condition, and to 1 intervention — of which Risperidone 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: NCT00166595 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Ohio, Michigan, North Carolina. 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 NCT00166595 about?

NCT00166595 is a clinical study titled "Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)". The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in ch...

What is the current status of trial NCT00166595?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2003-02. Estimated completion is 2005-03.

What conditions does trial NCT00166595 study?

This clinical trial studies the following conditions: Child Development Disorders, Pervasive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00166595?

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

Who is sponsoring clinical trial NCT00166595?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00166595 being conducted?

This trial has 4 study locations across Michigan, North Carolina, Ohio. 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