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

Sumitomo Pharma America, Inc.61 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Lurasidone 80mg tabletDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

* 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

Locations (21)

Birmingham Psychiatry Pharmaceutical

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study

Time frame: 1 year

Data from ClinicalTrials.gov

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