Measurement of Risperidone and 9-Hydroxyrisperidone in Plasma and Saliva

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Paliperidone Palmitate; Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.