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Asenapine vs Olanzapine in Acute Bipolar I Mania (ARES)
NCT00159744Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2004
- Primary completion
- Apr 2006
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Drugs
- asenapine
- Conditions
- bipolar I disorder
01
Overview
Phase 3, randomised, double-blind trial of asenapine in bipolar I disorder (3 arms), sponsored by Organon & Co. Primary endpoint: Young Mania Rating Scale at 21 days. Started Nov 2004; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Asenapine
Sublingual asenapine for 3 weeks
Olanzapine
Olanzapine for 3 weeks
Placebo
Placebo for 3 weeks
03
Who it enrols
Patients with DSM-IV bipolar I disorder, current manic or mixed episode, excluding rapid cyclers and those with other primary psychiatric or unstable medical conditions.
04
Endpoints
Primary
Young Mania Rating Scale
Secondary
Clinical Global Impression
Positive and Negative Symptom Scale
Montgomery Asberg Depression Rating Scale
Readiness for Discharge Questionnaire
CogState Cognition Battery
Short Form-36 Health Survey
Treatment Satisfaction Questionnaire for Medication
Simpson Angus Rating Scale
05
Results
Primary endpoints met
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