A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.
A Randomized Open-Label, Rater Blinded Assessment of Optimal Treatment Change Strategy to Risperidone for Patients Intolerant of Olanzapine
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the second phase of this study, investigators will assess the effectiveness of behavioral therapy in reducing body weight in risperdone-treated patients who are overweight or have problems with diabetes or blood sugar.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 15, 2006
CompletedFirst Posted
Study publicly available on registry
September 19, 2006
CompletedApril 27, 2010
April 1, 2010
September 15, 2006
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.
Secondary Outcomes (1)
The change from baseline in Client Satisfaction Questionnaire (CSQ-8) score at week 14 of Phase 2 and the change from baseline in Global Assessment of Functioning (GAF) score at week 14 of Phase 2.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder
- Taking a stable dose of olanzapine for at least 30 days
- Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months
- Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism
You may not qualify if:
- Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone
- A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization
- Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances
- Diagnosis of substance dependence
- Pregnant or nursing female, or those lacking adequate contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Related Publications (1)
Ganguli R, Brar JS, Mahmoud R, Berry SA, Pandina GJ. Assessment of strategies for switching patients from olanzapine to risperidone: a randomized, open-label, rater-blinded study. BMC Med. 2008 Jun 30;6:17. doi: 10.1186/1741-7015-6-17.
PMID: 18590519DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen, LP Clinical Trial
Janssen, LP
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 15, 2006
First Posted
September 19, 2006
Study Start
February 1, 2001
Study Completion
May 1, 2002
Last Updated
April 27, 2010
Record last verified: 2010-04