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

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Lurasidone 80mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088621

D1050199

Details and patient eligibility

About

A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Full description

Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Enrollment: 61 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
• Successfully completed
• OR
• Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Lurasidone 80 mg tablet

Experimental group

Description:

Lurasidone 80mg oral tablet taken once a day

Treatment:

Drug: Lurasidone 80mg tablet