Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Risperidone; Drug: SM-13496 (lurasidone HCl)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711269

JapicCTI-080585 (Registry Identifier)

D1001002

Details and patient eligibility

About

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Enrollment: 460 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Patient meets DSM-IV criteria for schizophrenia.
• Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
• Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.

Main Exclusion Criteria:

• Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
• Patient has Parkinson's disease.
• Patient has a history or complication of malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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460 participants in 4 patient groups, including a placebo group

SM-13496 (lurasidone HCl) 40mg

Experimental group

Description:

SM-13496 40 mg was administered orally once daily.

Treatment:

Drug: SM-13496 (lurasidone HCl)

Drug: SM-13496 (lurasidone HCl)

SM-13496 (lurasidone HCl) 80mg

Experimental group

Description:

SM-13496 80mg was administered orally once daily.

Treatment:

Drug: SM-13496 (lurasidone HCl)

Drug: SM-13496 (lurasidone HCl)

Placebo

Placebo Comparator group

Description:

Placebo was administered orally twice daily.

Treatment:

Drug: Placebo

Risperidone

Active Comparator group

Description:

Risperidone was administered orally twice daily.

Treatment:

Drug: Risperidone