Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

February 1, 2008

Last Updated Date

March 17, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in total PANSS score from baseline to the end of the double blind treatment period. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00615433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CGI-S from baseline to the end of the double-blind treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Official Title ^ICMJE

A Phase 3 Randomized, Placebo-and Active Comparator Controlled, CLinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

Brief Summary

Lurasidone HCl is a compond developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Lurasidone HCl

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

480

Completion Date

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or iinjury to self, others or property.
Any chronic organic disease of the CNS (other than schizophrenia).
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christina D Butler, MS, CCRA

201-228-8041

cbutler@dsp-a.com

Location Countries ^ICMJE

United States, Bulgaria, Colombia, Former Serbia and Montenegro, India, Lithuania, Peru, Philippines

Administrative Information

NCT ID ^ICMJE

NCT00615433

Responsible Party

Christina Butler/Associate Manager, Dainippon Sumitomo Pharma America, Inc

Study ID Numbers ^ICMJE

D1050231

Study Sponsor ^ICMJE

Dainippon Sumitomo Pharma America

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John Sonnenberg

Uptown Research Institute, LLC

Information Provided By

Dainippon Sumitomo Pharma America

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP