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

ISRCTN	ISRCTN16838597
DOI	https://doi.org/10.1186/ISRCTN16838597
ClinicalTrials.gov number	NCT00549718
Secondary identifying numbers	D1050229

Submission date: 06/02/2008
Registration date: 21/04/2008
Last edited: 22/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shelda Alcock
Scientific

Dainippon Sumitomo Pharma Europe Ltd (Europe)
First Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	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
Study objectives	Lurasidone HCI demonstrates greater efficacy, safety and tolerability in acutely psychotic patients with schizophrenia as compared to placebo.
Ethics approval(s)	Ethics approval received from: 1. India: Ethics Committee, Seth Vadilal Sarabhai General Hospital, 04/04/2008 2. Romania: National Ethics Committee, 21/02/2008 3. Russia: Ethics Committee at the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, 19/02/2008 4. Ukraine: Central Ethics Commission, 07/02/2008 5. France: CPP Sud Méditerranée III Ethics Committee, 16/04/2008 Ethics approval expected from: 6. Malaysia: Medical Research and Ethics Committee; submitted 27/12/2007, expected approval date: 10/03/2008
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Lurasidone hydrochloride (HCl)
Primary outcome measure	Change in total positive and negative syndrome scale (PANSS) score from baseline to the end of the double blind treatment period (six weeks).
Secondary outcome measures	Clinical global impression of severity (CGI-S) from baseline to the end of the double-blind treatment (six weeks).
Overall study start date	01/11/2007
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Approximately 480 patients
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/11/2007
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

England
France
India
Malaysia
Romania
Russian Federation
Ukraine
United Kingdom
United States of America

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd (Europe)

London
SW1E 6QT
United Kingdom

Sponsor information

Dainippon Sumitomo Pharma America Inc. (USA)
Industry

One Bridge Plaza
Suite 510
Fort Lee
New Jersey
07024
United States of America

"ROR"	https://ror.org/04vwbmb32

Funders

Funder type

Industry

Dainippon Sumitomo Pharma Co Ltd (Japan)
Private sector organisation / For-profit companies (industry)

Alternative name(s): Dainippon Sumitomo Pharma Co., Ltd.
Location: Japan

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/05/2013		Yes	No

Editorial Notes

22/03/2016: added link to results - basic reporting, publication reference added.