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Long-term Asenapine vs Olanzapine in Schizophrenia Extension Study
NCT00212771Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Sep 2006
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Drugs
- asenapine
- Conditions
- schizophreniaschizoaffective disorder
01
Overview
Phase 3, randomised, double-blind trial of asenapine in schizophrenia and schizoaffective disorder (2 arms), sponsored by Organon & Co. Primary endpoint: Total Positive and Negative Syndrome Scale Score. Started Sep 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Asenapine
Asenapine 10-20 mg/day
Olanzapine
Olanzapine 10-20 mg/day
03
Who it enrols
Patients with schizophrenia or schizoaffective disorder who have completed 12 months of treatment under protocol 25517.
04
Endpoints
Primary
Total Positive and Negative Syndrome Scale Score
Secondary
Positive and Negative Syndrome Scale Subscale Scores
Clinical Global Impressions-Severity
Patient Functionality and Subjective Well-being
Calgary Depression Scale for Schizophrenia Score
Resource Utilization
Extrapyramidal Symptoms
Adverse Events
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