A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia
1 other identifier
interventional
180
1 country
22
Brief Summary
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of 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 May 2004
Shorter than P25 for phase_2 schizophrenia
22 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
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 30, 2004
CompletedFirst Posted
Study publicly available on registry
August 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedResults Posted
Study results publicly available
March 1, 2011
CompletedApril 8, 2016
March 1, 2016
7 months
July 30, 2004
February 1, 2011
March 10, 2016
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.
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 (2)
Lurasidone
EXPERIMENTAL80 mg AM dosing once daily
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
- The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception
You may not qualify if:
- The patient has used an investigational drug within the past 30 days
- The patient has participated in a previous study of this compound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, 35209, United States
Summit Research Group
Little Rock, Arkansas, 72211, United States
Comprehensive NeuroScience
Cerritos, California, 90703, United States
Collaborative Neuro Science Network, Inc.
Garden Grove, California, 92845, United States
Optimum Health Services
La Mesa, California, 91942, United States
California Clinical Trials
San Diego, California, 92123, United States
CNRI, LLC San Diego
San Diego, California, 92126, United States
Pacific Clinical Research
Upland, California, 91786, United States
Comprehensive NeuroScience, Inc
Washington D.C., District of Columbia, 20016, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
The Segal Institute
North Miami, Florida, 33161, United States
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Comprehensive Neuroscience, Inc.
Hoffman Estates, Illinois, 60194, United States
Robert Lynn Horne, MD, Suite 4
Las Vegas, Nevada, 89102, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139, United States
Community Clinical Research
Austin, Texas, 78729, United States
Future Search Trials
Austin, Texas, 78756, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
CBH Health, L.L.C - Dominion Hospital
Falls Church, Virginia, 22044, United States
Related Publications (4)
Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, Loebel A. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Jun;70(6):829-36. doi: 10.4088/JCP.08m04905. Epub 2009 Jun 2.
PMID: 19497249RESULTHopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
PMID: 39144777DERIVEDHopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
PMID: 34751928DERIVEDNasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
PMID: 24955752DERIVED
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
July 30, 2004
First Posted
August 2, 2004
Study Start
May 1, 2004
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
April 8, 2016
Results First Posted
March 1, 2011
Record last verified: 2016-03