CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00783783
NCT00783783N/ACompleted

CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS

Children's Hospital Medical Center, Cincinnati·observational·Posted Nov 3, 2008·Updated Dec 11, 2012

In Brief

An observational study for Psychiatric Disorders and Neurodevelopmental Disorders. Completed, enrolled 47 participants across 1 site.

Detailed 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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2008
Enrollment StartNov 1, 2008
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.7 years ago