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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: SM-13496 40mg; Drug: SM-13496 80mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614899

JapicCTI-121859 (Registry Identifier)

D1001056

Details and patient eligibility

About

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

Enrollment: 457 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient meets DSM-IV-TR criteria for schizophrenia.
• Patient is aged 18 through 74 years at informed consent.
• Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

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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457 participants in 3 patient groups, including a placebo group

SM-13496 40mg

Experimental group

Treatment:

Drug: SM-13496 40mg

SM-13496 80mg

Experimental group

Treatment:

Drug: SM-13496 80mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo