Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children - Full Text View

Sponsored by:	Stony Brook University
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00790075

Purpose

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.

Condition	Intervention	Phase
Agitation	Drug: risperidone	Phase IV

MedlinePlus related topics: Children's Health

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

reduced time to end of agitation episode compared to unmedicated agitation episode [ Time Frame: Duration of "time out" or time in seclusion ]

Enrollment:	24
Study Start Date:	January 2003
Study Completion Date:	December 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Intervention Details:

liquid risperidone was administered on a mg/kg basis to a child needing seclusion. 0.015mg/kg was the start dose. Dose was increased to 0.02mg/kg if duration of episode was >30 minutes.

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Eligibility

Ages Eligible for Study:	4 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790075

Locations

United States, New York
StonyBrook University Hospital (StonyBrook University School of Medicine)
StonyBrook, New York, United States, 11794

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator:

Gabrielle A Carlson, MD

StonyBrook University School of Medicine

More Information

Responsible Party:	StonyBrook University School of Medicine ( Gabrielle A. Carlson, MD )
Study ID Numbers:	20034920
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790075
Health Authority:	United States: Institutional Review Board

Keywords provided by Stony Brook University:

agitation
Episodes of agitation regardless of diagnosis

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Risperidone
Neurologic Manifestations

Psychomotor Agitation
Neurobehavioral Manifestations
Dyskinesias
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Psychomotor Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009