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

This study has been completed.
Sponsor:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00790075
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children

Resource links provided by NLM:


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:
    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.
  Show Detailed Description

  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
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, see Learn About Clinical Studies.

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

No publications provided

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

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
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 20, 2014