Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to demonstrate safety and efficacy of liquid risperidone in psychiatrically hospitalized children, ages 4-12, who would be put in seclusion or restraint, or given an intramuscular injection of diphenhydramine because of their out-of-control behavior if not medicated with risperidone. The first part of the study will: 1) develop appropriate oral doses of medication to reduce out of control or agitated behavior effectively with the fewest side effects, and 2) develop a rating system to measure the children's behavior i.e. level of improvement, sedation, and untoward effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• consented, psychiatrically hospitalized child between the ages of 4-12 whose agitated behavior would otherwise require seclusion

Exclusion Criteria:

• prior side effects taking risperidone