Back to resultsHaloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates
Primary Purpose
Psychosis, Aggression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis
Eligibility Criteria
Inclusion Criteria:age 18 or over, psychotic disorder diagnosed on SCID, inmate at correctional facility for at least 2 weeks - Exclusion Criteria: active withdrawal from substances of abuse, non-psychotic individuals, pregnant women, people unable to give informed consent, patients on mood stabilizers -
Sites / Locations
- University of connecticut health center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00203775
First Posted
September 12, 2005
Last Updated
October 12, 2006
Sponsor
University of Connecticut
Collaborators
Janssen Pharmaceutica N.V., Belgium
1. Study Identification
Unique Protocol Identification Number
NCT00203775
Brief Title
Haloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates
Official Title
Efficacy of Risperidone Versus Haloperidol in the Treatment of Aggression and Hostility in Psychotic Inmates
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Terminated
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Connecticut
Collaborators
Janssen Pharmaceutica N.V., Belgium
4. Oversight
5. Study Description
Brief Summary
This study examines the efficacy of haldol versus risperdal in the treatment of aggression in psychotic prison inmates. It is hypothsized that risperdal will be more effective in decreasing aggression than haldol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Aggression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
risperidone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:age 18 or over, psychotic disorder diagnosed on SCID, inmate at correctional facility for at least 2 weeks -
Exclusion Criteria: active withdrawal from substances of abuse, non-psychotic individuals, pregnant women, people unable to give informed consent, patients on mood stabilizers
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine f lewis, md
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of connecticut health center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Haloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates
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