Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

This study is currently recruiting participants.

Verified by Dainippon Sumitomo Pharma America, March 2008

Sponsored by:	Dainippon Sumitomo Pharma America
Information provided by:	Dainippon Sumitomo Pharma America
ClinicalTrials.gov Identifier:	NCT00615433

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Lurasidone HCl	Phase III

MedlinePlus related topics: Mental Health Schizophrenia

Drug Information available for: SM-13496 Lurasidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Dainippon Sumitomo Pharma America:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	480
Study Start Date:	January 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

40mg/day, 120mg/day, placebo or active comparator for 6 weeks (acute phase). Open label lurasidone for 6 months (extension)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615433

Contacts

Contact: Christina D Butler, MS, CCRA

201-228-8041

cbutler@dsp-a.com

Show 50 Study Locations

Sponsors and Collaborators

Dainippon Sumitomo Pharma America

Investigators

Principal Investigator:

John Sonnenberg

Uptown Research Institute, LLC

More Information

Responsible Party:	Dainippon Sumitomo Pharma America, Inc ( Christina Butler/Associate Manager )
Study ID Numbers:	D1050231
Study First Received:	February 1, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00615433
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 14, 2009