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Lurasidone in acute schizophrenia (SM-13496-D1050049)
NCT00044044Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2002
- Primary completion
- May 2003
- Countries
- 1
- Sponsor
- Sumitomo Pharma America
- Modality
- Small Molecules
- Drugs
- lurasidone
- Conditions
- schizophrenia
01
Overview
Phase 2, randomised, double-blind trial of lurasidone in schizophrenia (5 arms), sponsored by Sumitomo Pharma America. Primary endpoint: Brief Psychiatric Rating Scale at 6 weeks. Started Jul 2002; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Lurasidone 20 mg
Lurasidone 20 mg tablets daily
Lurasidone 40 mg
Lurasidone 40 mg tablets daily
Lurasidone 80 mg
Lurasidone 80 mg (2 x 40 mg) tablets daily
Haloperidol 10 mg
Haloperidol 10 mg tablets daily
Placebo
Matching placebo tablets daily
03
Who it enrols
Patients aged 18-64 with schizophrenia experiencing acute exacerbation, hospitalized within 3 weeks, with a BPRS score >= 42 and specific PANSS positive symptoms.
04
Endpoints
Primary
Brief Psychiatric Rating Scale
Secondary
Positive and Negative Syndrome Scale
Clinical Global Impression of Severity
Montgomery Asberg Depression Rating Scale
05
Results
Not all primary endpoints met
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