NCT00790075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

1.4 years

First QC Date

November 12, 2008

Last Update Submit

November 12, 2008

Conditions

Agitation

Keywords

agitationEpisodes of agitation regardless of diagnosis

Outcome Measures

Primary Outcomes (1)

  • reduced time to end of agitation episode compared to unmedicated agitation episode

    Duration of "time out" or time in seclusion

Interventions

risperidoneDRUG

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.

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • consented, psychiatrically hospitalized child between the ages of 4-12 whose agitated behavior would otherwise require seclusion

You may not qualify if:

  • prior side effects taking risperidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StonyBrook University Hospital (StonyBrook University School of Medicine)

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Risperidone

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gabrielle A Carlson, MD

    StonyBrook University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

January 1, 2003

Primary Completion

June 1, 2004

Study Completion

December 1, 2004

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

US(1)