Safety and Tolerability Study of Drug to Treat Schizophrenia
A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia
1 other identifier
interventional
98
1 country
26
Brief Summary
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started Sep 2002
Shorter than P25 for phase_2 schizophrenia
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2002
CompletedFirst Posted
Study publicly available on registry
August 20, 2002
CompletedStudy Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedResults Posted
Study results publicly available
May 19, 2011
CompletedApril 17, 2014
March 1, 2014
1.2 years
August 16, 2002
February 16, 2011
March 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
6-months
Study Arms (3)
Lurasidone 20 mg
EXPERIMENTALLurasidone 20 mg oral tablet
Lurasidione 40 mg
EXPERIMENTALLurasidone 40 mg oral tablet
Lurasidone 80mg
EXPERIMENTALLurasidone 80mg oral tablet
Interventions
Eligibility Criteria
You may qualify if:
- Successful completion of participation in protocol #D1050049
You may not qualify if:
- Substance abuse
- Prolactin level of ≥200ng/mL at baseline
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, 35209, United States
Institute for Psychopharmacology Research
Cerritos, California, 90703, United States
CNS Network
Garden Grove, California, 92845, United States
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Optimum Health Services
La Mesa, California, 91942, United States
University of California, Irvine
Orange, California, 92868, United States
California Neuropsychopharmacology Clinical Research Institute
San Diego, California, 92126, United States
Psychiatric Institute of Washington
Washington D.C., District of Columbia, 20016, United States
Comprehensive Neuroscience. Inc.
Melbourne, Florida, 32935, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
University of South Florida
Tampa, Florida, 33613, United States
Coordinated Research of Florida, Inc
Winter Park, Florida, 32789, United States
Hawaii Research Center
Honolulu, Hawaii, 96826, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60194, United States
American Medical Research
Oak Brook, Illinois, 60523, United States
Lake Mead Hospital
North Las Vegas, Nevada, 89030, United States
Comprehensive Clinical Research, CNS
Clementon, New Jersey, 08021, United States
ClinSearch, Inc.
Kenilworth, New Jersey, 07033, United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Community Clinical Research
Austin, Texas, 78756, United States
FutureSearch Trials
Austin, Texas, 78756, United States
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, 77401, United States
St. Paul Medical Center
Dallas, Texas, 75235, United States
CNS, Inc.
Falls Church, Virginia, 22041, United States
Medstream, Inc.
Milwaukee, Wisconsin, 53210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro, PhD
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2002
First Posted
August 20, 2002
Study Start
September 1, 2002
Primary Completion
November 1, 2003
Study Completion
November 1, 2003
Last Updated
April 17, 2014
Results First Posted
May 19, 2011
Record last verified: 2014-03