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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Psychiatry Pharmaceutical, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lurasidone 80mg tablet

Drug

Other names: Lurasidone

Primary outcomes

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

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Aug 2, 2004
Registry last updated: Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed