Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00790075
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Information provided by:
Stony Brook University

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 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 or disease Intervention/treatment Phase
Agitation Drug: risperidone Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children
Study Start Date : January 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Intervention Details:
  • Drug: risperidone
    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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00790075

Layout table for location information
United States, New York
StonyBrook University Hospital (StonyBrook University School of Medicine)
StonyBrook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Layout table for investigator information
Principal Investigator: Gabrielle A Carlson, MD StonyBrook University School of Medicine
Layout table for additonal information
Responsible Party: Gabrielle A. Carlson, MD, StonyBrook University School of Medicine Identifier: NCT00790075    
Other Study ID Numbers: 20034920
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008
Keywords provided by Stony Brook University:
Episodes of agitation regardless of diagnosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents