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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.
ClinicalTrials.gov Identifier: NCT00790075
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:

Study Description
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

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Primary Completion Date : June 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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: Gabrielle A. Carlson, MD, StonyBrook University School of Medicine
ClinicalTrials.gov Identifier: NCT00790075     History of Changes
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:
agitation
Episodes of agitation regardless of diagnosis

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Risperidone
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