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

Completed · Phase 4

Conditions studied: Agitation

In brief

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.

Key facts

Study ID

NCT00790075

Run by

Stony Brook University

People needed

24

Starts

2003-01-01

Expected to finish

2004-12-01

Last updated by the study team

2008-11-13

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• prior side effects taking risperidone

Where it is running

• StonyBrook University Hospital (StonyBrook University School of Medicine) — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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