Status:
COMPLETED
Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children
Lead Sponsor:
Stony Brook University
Conditions:
Agitation
Eligibility:
All Genders
4-12 years
Phase:
PHASE4
Brief 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 intramus...
Detailed Description
A. Develop an appropriate dose structure for risperidone. Children needing oral medication will be initially offered a safe minimal dose (0.015 mg/kg) dose of risperidone (between 0.3 and 0.6mg for ch...
Eligibility Criteria
Inclusion
- consented, psychiatrically hospitalized child between the ages of 4-12 whose agitated behavior would otherwise require seclusion
Exclusion
- prior side effects taking risperidone
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00790075
Start Date
January 1 2003
End Date
December 1 2004
Last Update
November 13 2008
Active Locations (1)
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1
StonyBrook University Hospital (StonyBrook University School of Medicine)
Stony Brook, New York, United States, 11794