Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
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ClinicalTrials.gov Identifier: NCT00166595 |
Recruitment Status
:
Completed
First Posted
: September 14, 2005
Last Update Posted
: January 28, 2014
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Tracking Information | |||
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First Submitted Date ICMJE | September 9, 2005 | ||
First Posted Date ICMJE | September 14, 2005 | ||
Last Update Posted Date | January 28, 2014 | ||
Study Start Date ICMJE | February 2003 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00166595 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD) | ||
Official Title ICMJE | Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD) | ||
Brief 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. | ||
Detailed Description | To the knowledge of the investigators there are no studies documenting the pharmacokinetics and pharmacogenetics of risperidone in children with PDD. Currently the PPRU network is conducting a PK study whose aim is to establish a new enantio-selective micro-assay methodology and to generate preliminary population PK data of risperidone and its metabolites in PDD. This study focuses on pharmacogenetic evaluation of PDD patients having little or no effect, those that are unusually sensitive and those experiencing drug toxicity/adverse events at standard risperidone dosages. In this study two 5 ml blood samples will be drawn at a regulary scheduled PK visit. Alternatively pooled waste blood samples or a buccal swab can be obtained. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE | Child Development Disorders, Pervasive | ||
Intervention ICMJE | Drug: Risperidone | ||
Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE |
100 | ||
Original Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | March 2005 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 4 Years to 21 Years (Child, Adult) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00166595 | ||
Other Study ID Numbers ICMJE | PPRU 10545s | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Children's Hospital Medical Center, Cincinnati | ||
Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||
Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Children's Hospital Medical Center, Cincinnati | ||
Verification Date | July 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |