Lurasidone HCL - A 6-Week Phase 3 Study of Patients With Acute Schizophrenia. - Full Text View

Sponsored by:	Dainippon Sumitomo Pharma America
Information provided by:	Dainippon Sumitomo Pharma America
ClinicalTrials.gov Identifier:	NCT00790192

Purpose

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Lurasidone HCl Drug: quetiapine XR Drug: Placebo	Phase III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate SM-13496 Lurasidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)

Further study details as provided by Dainippon Sumitomo Pharma America:

Primary Outcome Measures:

Primary Efficacy Endpoint: Mean change from baseline in total PANSS score at endpoint (Week 6). [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Primary Safety Endpoints: The proportion of subjects with: • Adverse Events (AEs) • Discontinuations due to AEs • Serious Adverse Events (SAEs) [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Key Secondary Efficacy Endpoint: • Mean change from baseline in CGI-S score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Key Secondary Efficacy Endpoint: • Mean change from baseline in PANSS total score on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental	Drug: Lurasidone HCl Lurasidone HCl
2: Experimental	Drug: Lurasidone HCl Lurasidone HCl
3: Active Comparator	Drug: quetiapine XR Active Comparator
4: Placebo Comparator	Drug: Placebo Placebo

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 injury 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: NCT00790192

Contacts

Contact: Kaushik Sarma, M.D.

201-228-8040

ksarma@dsp-a.com

Show 31 Study Locations

Sponsors and Collaborators

Dainippon Sumitomo Pharma America

More Information

Responsible Party:	Dainippon Sumitomo Pharma America, Inc. ( Josephine Cucchiaro, Ph.D. / Senior Director, Clinical Development )
Study ID Numbers:	D1050233
Study First Received:	November 10, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790192
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dainippon Sumitomo Pharma America:

Acute Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009