A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Lurasidone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088634

D1050196

Details and patient eligibility

About

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Full description

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Enrollment: 180 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
• The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
• If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion criteria

• The patient has used an investigational drug within the past 30 days
• The patient has participated in a previous study of this compound

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups, including a placebo group

Lurasidone

Experimental group

Description:

80 mg AM dosing once daily

Treatment:

Drug: Lurasidone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo