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NCT00783783 · ClinicalTrials.gov registry record

CYP2D6 Pharmacogenetics in Risperidone-Treated Children

A clinical trial of Neurodevelopmental Disorders and Psychiatric Disorders, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
47
Enrollment target
1
Study location

NCT00783783 is a study of Neurodevelopmental Disorders and Psychiatric Disorders that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 47 participants, below the 580-participant average among 27 other Neurodevelopmental Disorders trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00783783, a study of Neurodevelopmental Disorders and Psychiatric Disorders, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
47 participants
Enrollment target
1
Study location

Study Summary

Risperidone is an important medication used to treat children with psychiatric illnesses or neurodevelopmental disorders, such as autism. Despite excellent symptom control, the potential for side effects is worrisome. Treating these disorders is difficult because not everyone responds the same way to the same risperidone dose. One reason for this is genetic differences in how people break down the drug. Understanding these differences will help clinicians choose a dose and better predict the response so patients will be treated successfully with a lower risk for side effects. This study will research these genetic differences in children with psychiatric or neurodevelopmental disorders. Hypothesis: The inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and clinical response in patients with psychiatric or neurodevelopmental disorders is associated with identifiable pharmacogenetic factors, such as CYP2D6 single nucleotide polymorphisms (SNPs).

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2008-11
Est. Completion 2011-06

What the Registry Record Tells You About NCT00783783

The ClinicalTrials.gov registry entry for NCT00783783 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 580-participant average among 27 other Neurodevelopmental Disorders trials with a reported enrollment target (92% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Neurodevelopmental Disorders appearing as the primary indexed condition, and to 0 interventions.

NCT00783783 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT00783783 about?

NCT00783783 is a clinical study titled "CYP2D6 Pharmacogenetics in Risperidone-Treated Children". Risperidone is an important medication used to treat children with psychiatric illnesses or neurodevelopmental disorders, such as autism. Despite excellent symptom control, the potential for side effects is worrisome. Treating these disorders is difficult because not everyone responds the same way t...

What is the current status of trial NCT00783783?

This trial is currently completed. The enrollment target is 47 participants. The study started on 2008-11. Estimated completion is 2011-06.

What conditions does trial NCT00783783 study?

This clinical trial studies the following conditions: Neurodevelopmental Disorders, Psychiatric Disorders.

Who is sponsoring clinical trial NCT00783783?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00783783 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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