Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia (PEARL 3 Ext)

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Schizophrenia

Treatments: Drug: Lurasidone HC1; Drug: Quetiapine XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789698

D1050234

Details and patient eligibility

About

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Entry Criteria:

• Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Inclusion Criteria:

• Completed all required assessments on the final study visit in Study D1050233.
• Suitable for treatment in an outpatient setting.

Exclusion Criteria:

• Any chronic organic disease of the CNS (other than schizophrenia).
• Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Lurasidone HC1

Experimental group

Treatment:

Drug: Lurasidone HC1

Quetiapine

Active Comparator group

Treatment:

Drug: Quetiapine XR