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Lurasidone in Schizophrenia
NCT00711269Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2008
- Primary completion
- Apr 2010
- Countries
- 3
- Sponsor
- Sumitomo Pharma
- Modality
- Small Molecules
- Drugs
- lurasidone
- Conditions
- schizophrenia
01
Overview
Phase 3, randomised, double-blind trial of lurasidone in schizophrenia (4 arms), sponsored by Sumitomo Pharma. Primary endpoint: Change From Baseline in the Positive and Negative Syndrome Scale Total Score at 6 weeks. Started Jun 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Lurasidone 40mg
Lurasidone 40 mg/day
Lurasidone 80mg
Lurasidone 80 mg/day
Placebo
Placebo
Risperidone
Risperidone (Active Comparator)
03
Who it enrols
Patients with DSM-IV schizophrenia aged 18-75, excluding those with history of NMS, water intoxication, paralytic ileus, Parkinson's disease, or malignancy.
04
Endpoints
Primary
Change From Baseline in the Positive and Negative Syndrome Scale Total Score
Secondary
Change From Baseline in the PANSS Positive Subscale Score
Change From Baseline in the PANSS Negative Subscale Score
Change From Baseline in the PANSS General Psychopathology Subscale Score
Proportion of Participants With Treatment-emergent Adverse Events
Proportion of Participants With TEAEs Leading to Discontinuation
Proportion of Participants With Treatment-emergent Serious Adverse Events
05
Results
Not all primary endpoints met
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