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Brexpiprazole in Early Episode Schizophrenia
NCT02013622Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2013
- Primary completion
- Sep 2014
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- schizophrenia
01
Overview
Phase 3, open-label, single-arm trial of brexpiprazole orally disintegrating tablet in schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization. Primary endpoint: Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale Total Score. Started Nov 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Brexpiprazole
Brexpiprazole flexible dose (1-4 mg/day)
03
Who it enrols
Adult outpatients aged 18-35 with early-episode schizophrenia (<= 5 years since onset) and PANSS Total Score <= 80.
04
Endpoints
Primary
Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale Total Score
Secondary
Mean Change From Baseline to Week 16 Scores of Negative Scale Items
Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity Score
Mean Clinical Global Impression-Improvement Score
Mean Change From Baseline to Week 16 in Personal and Social Performance Total Score
Mean Change From Baseline to Week 16 in Specific Levels of Functioning Total Score
Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index Total Score
Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication Total Score
Mean Change From Baseline to Week 16 in Go/No-Go Task
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