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The Effects of Risperidone and Olanzapine on Thinking

Primary Purpose

Schizophrenia, Psychotic Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Olanzapine
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognition, antipsychotic medication, information processing, social cognition, Psychotic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with schizophrenia disorder by a DSM IV. Competent to sign informed consent No history of poor response to Risperdal and Zyprexa No organic brain disease Exclusion Criteria: Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.

Sites / Locations

  • VA Greater Los Angeles Healthcare System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 14, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
Collaborators
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00108368
Brief Title
The Effects of Risperidone and Olanzapine on Thinking
Official Title
The Cognitive Effects of Risperidone and Olanzapine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Janssen, LP

4. Oversight

5. Study Description

Brief Summary
The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition. Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
Keywords
schizophrenia, cognition, antipsychotic medication, information processing, social cognition, Psychotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
Olanzapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with schizophrenia disorder by a DSM IV. Competent to sign informed consent No history of poor response to Risperdal and Zyprexa No organic brain disease Exclusion Criteria: Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22688151
Citation
Sergi M, Green M, Widmark C, Reist C, Erhart S, Braff D, Kee K, Marder S, Mintz J. Social Cognition and Neurocognition: Effects of Risperidone, Olanzapine, and Haloperidol. Am J Psychiatry. 2007 Oct 1;164(10):1585-1592. doi: 10.1176/appi.ajp.2007.06091515.
Results Reference
derived
PubMed Identifier
17898351
Citation
Sergi MJ, Green MF, Widmark C, Reist C, Erhart S, Braff DL, Kee KS, Marder SR, Mintz J. Social cognition [corrected] and neurocognition: effects of risperidone, olanzapine, and haloperidol. Am J Psychiatry. 2007 Oct;164(10):1585-92. doi: 10.1176/appi.ajp.2007.06091515. Erratum In: Am J Psychiatry. 2007 Nov;164(11):1766.
Results Reference
derived

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The Effects of Risperidone and Olanzapine on Thinking

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