Status:
COMPLETED
Measurement of Risperidone and 9-Hydroxyrisperidone in Plasma and Saliva
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Patients Already Taking Risperidone for Clinical Indications
Eligibility:
All Genders
4-14 years
Brief Summary
The purpose of this research is to: (1) examine the secrection of risperidone (RIS) (Risperdal) and its metabolite, 9-OH-RIS, in saliva, (2) determine the concentration ratio of RIS and 9-OH-RIS betwe...
Detailed Description
The purpose of this research is to: (1) examine the secrection of risperidone (RIS) (Risperdal) and its metabolite, 9-OH-RIS, in saliva, (2) determine the concentration ratio of RIS and 9-OH-RIS betwe...
Eligibility Criteria
Inclusion
- aged 4 to 14 years, inclusive
- male or female
- any type of psychiatric diagnosis
- maintained on risperidone monotherapy for at least four weeks
- no medication adjustments for the last two weeks
- must be taking risperidone on a twice daily (morning and evening) schedule.
Exclusion
- significant medical condition (e.g., heart disease, hypertension, liver or renal failure, pulmonary disease, unstable seizure disorder)
- females of child-bearing potential who score positive of pregnancy test
- receiving concurrent medications that may either bind to or are a substrate for CYP 450 2D6 or inhibit/induce CYP 3A3/4 activity. These include: anti-HIV medications, azole antifungal medications, calcium channel antagonists, carbamazepine, cimetidine, macrolide antibiotics (erythromycin, clarithromycin), phenytoin, propoxyphene, rifampin, or tramadol.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
OBSERVATIONAL
End Date :
April 1 2003
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00395499
Start Date
May 1 2001
End Date
April 1 2003
Last Update
June 23 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
General Clinical Research Center
Columbus, Ohio, United States, 43210
2
The Nisonger Center
Columbus, Ohio, United States, 43210