A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
1 other identifier
interventional
356
1 country
34
Brief Summary
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Jul 2002
Shorter than P25 for phase_2 schizophrenia
34 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
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 16, 2002
CompletedFirst Posted
Study publicly available on registry
August 20, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedResults Posted
Study results publicly available
April 12, 2011
CompletedApril 17, 2014
March 1, 2014
10 months
August 16, 2002
February 1, 2011
March 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Baseline and 6 weeks
Secondary Outcomes (3)
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
Baseline and 6 weeks
Study Arms (5)
Lurasidone 20 mg
EXPERIMENTALLurasidone 20 mg tablets
Lurasidone 40 mg
EXPERIMENTALLurasidone 40 mg tablets
Lurasidone 80 mg
EXPERIMENTALLurasidone 2 40 mg tablets
Haloperidol 10mg
ACTIVE COMPARATORHaloperidol 10mg tablets
Placebo
PLACEBO COMPARATORMatching Placebo to Lurasidone and Haloperidol
Interventions
Eligibility Criteria
You may qualify if:
- The patient has a primary diagnosis of schizophrenia
- The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
- The patient has had a duration of illness of at least one year.
- The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
- The patient is able to remain off antipsychotic medication for a 4 day washout period
You may not qualify if:
- The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
- The patient is considered treatment resistant-Substance abuse-Prolactin level of \> 200 ng/mL at baseline
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
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
Affiliated Research Institute
San Diego, California, 92108, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego, California, 92126, United States
Comprehensive Neuroscience. Inc.
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
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Carman Research
Smyrna, Georgia, 30080, 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
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850, United States
Lake Mead Hospital
North Las Vegas, Nevada, 89030, United States
Comprehensive Clinical Research CNS, PC
Clementon, New Jersey, 08021, United States
ClinSearch, Inc.
Kenilworth, New Jersey, 07033, United States
Psychiatric Professional Services Inc
Cincinnati, Ohio, 45267, United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139, United States
Albert Einstein Medical Center - Dept. of Psychiatry
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
University Hills Clinical Research
Dallas, Texas, 75235, United States
CNS, Inc.
Falls Church, Virginia, 22041, United States
Northwest Clinical Research Center
Belleview, Washington, 98004, United States
Medstream, Inc.
Milwaukee, Wisconsin, 53210, United States
Related Publications (1)
Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.
PMID: 39831535DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro, Executive Director
- 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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- 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
July 1, 2002
Primary Completion
May 1, 2003
Study Completion
May 1, 2003
Last Updated
April 17, 2014
Results First Posted
April 12, 2011
Record last verified: 2014-03