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

NCT ID: NCT00088621

Last Updated: 2014-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lurasidone 80 mg tablet

Lurasidone 80mg oral tablet taken once a day

Group Type EXPERIMENTAL

Lurasidone 80mg tablet

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lurasidone 80mg tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lurasidone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham Psychiatry Pharmaceutical

Birmingham, Alabama, United States

Site Status

Summit Research Group

Little Rock, Arkansas, United States

Site Status

Comprehensive NeuroScience

Cerritos, California, United States

Site Status

Collaborative Neuro Science Network, Inc.

Garden Grove, California, United States

Site Status

Optimum Health Services

La Mesa, California, United States

Site Status

California Clinical Trials

San Diego, California, United States

Site Status

CA Neutopsychopharmacology Clinical Research Institute (CNRI)

San Diego, California, United States

Site Status

Pacific Clinical Research

Upland, California, United States

Site Status

Comprehensive NeuroScience, Inc

Washington D.C., District of Columbia, United States

Site Status

Segal Institute for Clinical Research

Fort Lauderdale, Florida, United States

Site Status

Segal Institute for Clinical Research

North Miami, Florida, United States

Site Status

University of South Florida, Department of Psychiatry and Behavioral Medicine

Tampa, Florida, United States

Site Status

Comprehensive Neuroscience, Inc.

Hoffman Estates, Illinois, United States

Site Status

Las Vegas, Nevada, United States

Site Status

CNS Research Institute

Clementon, New Jersey, United States

Site Status

Quantum Clinical Services Group

Philadelphia, Pennsylvania, United States

Site Status

Community Clinical Research

Austin, Texas, United States

Site Status

Future Search Trials

Austin, Texas, United States

Site Status

Claghorn Lesem Research Clinic, Inc.

Bellaire, Texas, United States

Site Status

InSite Clinical Research

DeSoto, Texas, United States

Site Status

CBH Health, L.L.C - Dominion Hospital

Falls Church, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1050199

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study in Schizophrenia Patients
NCT01086748 COMPLETED PHASE2
Lurasidone Extended Use Study
NCT01485640 COMPLETED PHASE3