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Abilify Maintena in acute schizophrenia
NCT01663532Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2012
- Primary completion
- Aug 2013
- Countries
- 3
- Modality
- Small Molecules
- Drugs
- aripiprazole
- Conditions
- schizophrenia
01
Overview
Phase 3, randomised, double-blind trial in schizophrenia comparing Aripiprazole IM Depot with Placebo (2 arms). Primary endpoint: Positive and Negative Syndrome Scale Total Score at 10 weeks. Started Oct 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Aripiprazole IM Depot
Aripiprazole IM Depot 400 mg (or 300 mg) every 4 weeks
Placebo
Matching placebo every 4 weeks
03
Who it enrols
Adults with schizophrenia experiencing an acute exacerbation, with a history of good response to antipsychotics, excluding those resistant to treatment or with significant suicide risk.
04
Endpoints
Primary
Positive and Negative Syndrome Scale Total Score
Secondary
Clinical Global Impression-Severity Scale
Positive and Negative Syndrome Scale Positive Subscale Score
Positive and Negative Syndrome Scale Negative Subscale Score
Personal and Social Performance Scale Score
Clinical Global Impression-Improvement Scale Score
Responder Rate Based on PANSS Total Score
05
Results
Primary endpoints met
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