Safety and Tolerability Study of Drug to Treat Schizophrenia

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Lurasidone 20 mg; Drug: Lurasidone 80mg; Drug: Lurasidone 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044005

D1050174

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful completion of participation in protocol #D1050049

Exclusion criteria

• Substance abuse
• Prolactin level of ≥200ng/mL at baseline
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 3 patient groups

Lurasidone 20 mg

Experimental group

Description:

Lurasidone 20 mg oral tablet

Treatment:

Drug: Lurasidone 20 mg

Lurasidione 40 mg

Experimental group

Description:

Lurasidone 40 mg oral tablet

Treatment:

Drug: Lurasidone 40 mg

Lurasidone 80mg

Experimental group

Description:

Lurasidone 80mg oral tablet

Treatment:

Drug: Lurasidone 80mg