Measurement of Risperidone and 9-Hydroxyrisperidone in Plasma and Saliva

Completed

Conditions studied: Patients Already Taking Risperidone for Clinical Indications

In brief

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 between plasma and saliva, and (3) compare the rate of decline in concentration of RIS and 9-OH-RIS in saliva and plasma by measurements at timed intervals during a single dosing interval.

Key facts

Study ID: NCT00395499
Run by: Ohio State University
People needed: 19
Starts: 2001-05-01
Expected to finish: 2003-04-01
Last updated by the study team: 2016-06-23

Who can join

Age: 4 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

General Clinical Research Center — Columbus, Ohio, United States
The Nisonger Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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