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ISRCTN
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ISRCTN16838597
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ClinicalTrials.gov identifier
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NCT00549718
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Public title
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A phase three randomised, placebo-controlled, clinical trial to study the safety and efficacy of three doses of lurasidone hydrochloride (HCl) in acutely psychotic patients with schizophrenia
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Scientific title
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Acronym
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N/A
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Serial number at source
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D1050229
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Study hypothesis
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Lurasidone HCI demonstrates greater efficacy, safety and tolerability in acutely psychotic patients with schizophrenia as compared to placebo.
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Ethics approval
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Ethics approval received from:
1. India: Ethics Committee, Seth Vadilal Sarabhai General Hospital on the 4th April 2008
2. Romania: National Ethics Committee on the 21st February 2008
3. Russia: Ethics Committee at the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation on the 19th February 2008
4. Ukraine: Central Ethics Commission on the 7th February 2008
Ethics approval expected from:
5. France: CPP Sud Méditerranée III Ethics Committee; submitted 07/01/2008, expected approval date: 09/03/2008
6. Malaysia: Medical Research and Ethics Committee; submitted 27/12/2007, expected approval date: 10/03/2008
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America, India, Malaysia, France, Romania, Ukraine, Russia
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Disease/condition/study domain
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Schizophrenia
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Participants - inclusion criteria
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1. Provide written informed consent and aged between 18 and 75 years of age, either sex
2. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for a primary diagnosis of schizophrenia
3. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study
4. Able and agrees to remain off prior antipsychotic medication for the duration of study
5. Good physical health on the basis of medical history, physical examination, and laboratory screening
6. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits
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Participants - exclusion criteria
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1. Considered by the investigator to be at imminent risk of suicide or injury to self, others or property
2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
3. Used investigational compound within 30 days
4. Clinically significant or history of alcohol abuse/alchoholism or drug abuse/dependence within the last 6 months
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Anticipated start date
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01/11/2007
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Anticipated end date
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31/07/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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Approximately 480 patients
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Interventions
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Six-week, randomised, double-blind multi-centre, parallel-group study to evaluate efficacy and safety of three doses of lurasidone HCl compared with placebo (oral use film-coated tablet). After 14 day screening period and seven-day placebo washout period, patients are randomly assigned to one of four treatment arms (lurasidone HCl 40 mg/day, 80 mg/day or 120 mg/day or placebo [1:1:1 ratio]). Patients randomised to lurasidone HCl 120 mg/day will take lurasidone HCl 80 mg for days 1 - 3 then 120 mg for remainder of study. Option to continue in 22-month open-label extension phase.
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Primary outcome measure(s)
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Change in total positive and negative syndrome scale (PANSS) score from baseline to the end of the double blind treatment period (six weeks).
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Secondary outcome measure(s)
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Clinical global impression of severity (CGI-S) from baseline to the end of the double-blind treatment (six weeks).
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Sources of funding
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Dainippon Sumitomo Pharma Co Ltd (Japan)
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Trial website
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Publications
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Contact name
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Dr
Shelda
Alcock
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Address
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Dainippon Sumitomo Pharma Europe Ltd (Europe)
First Floor, Southside
97-105 Victoria Street
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City/town
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London
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Zip/Postcode
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SW1E 6QT
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Country
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United Kingdom
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Sponsor
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Dainippon Sumitomo Pharma America Inc. (USA)
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Address
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One Bridge Plaza, Suite 510
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City/town
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Fort Lee, New Jersey
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Zip/Postcode
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07024
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Country
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United States of America
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Date applied
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06/02/2008
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Last edited
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21/04/2008
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Date ISRCTN assigned
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21/04/2008
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