A phase 3 randomised placebo- and active comparator-controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCL in acutely psychotic patients with schizophrenia

ISRCTN	ISRCTN33909010
DOI	https://doi.org/10.1186/ISRCTN33909010
ClinicalTrials.gov number	NCT00615433
Secondary identifying numbers	D1050231

Submission date: 26/02/2008
Registration date: 21/04/2008
Last edited: 05/08/2021

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

Ms Shelda Alcock
Scientific

Dainippon Sumitomo Pharma Europe Ltd
First Floor
Southside
97-105 Victoria Street
London
SE1E 6QT
United Kingdom

Study information

Study design	Randomised double-blind parallel-group study
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 3 randomised placebo- and active comparator-controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCL in acutely psychotic patients with schizophrenia
Study objectives	Lurasidone HCl demonstrates greater efficiency, safety and tolerability in acutely psychotic patients with schizophrenia as compared with placebo.
Ethics approval(s)	Ethics approval received from: 1. Bulgaria: Multicentre trials Ethics Committee (MEC), 29/04/2008 2. Colombia: Research Ethics Committee (Comite de Etica en Investigacion Servicios Psiquiatricos S.A.), 12/02/2008 3. Lithuania: Central EC, Lithuania Bioethics Committee, 27/02/2008 4. Serbia: Ethics Committee of Clinical Centre of Serbia, 12/02/2008 Ethics approval pending from: 5. India: Ethics Committee of the Hospital for Mental Health. Expected approval date: 30/04/2008 6. Peru: Research Ethics Committee (Comite de Etica en Investigacion Hospital Nacional Guillermo Almenara). Expected approval date: 20/04/2008 7. Philippines: National Ethics Committee/National Centre for Mental Health. Expected approval date: 29/06/2008
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	There is a 14-day screening period and a 7-day placebo washout period before randomisation of the participants for the acute phase of the trial. Acute phase: Patients will be randomly assigned to one of the four treatment arms in equal numbers: Arm 1: Lurasidone HCI 40 mg/day orally for 6 weeks Arm 2: Lurasidone HCl 120 mg/day orally for 6 weeks Arm 3: Olanzapine 15 mg (oral use film-coated tablet/capsule) for 6 weeks Arm 4: Placebo for 6 weeks Open label extension phase: All participants who complete the 6-week acute phase will be given treatment with open label lurasidone HCl (oral) for 6 months.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Lurasidone, olanzapine
Primary outcome measure	Change in total PANSS (the Positive And Negative Syndrome Scale) score from baseline to the end of the 6-week double-bind treatment period.
Secondary outcome measures	Clinical Global Impressions - Severity (CGI-S) from baseline to the end of the double-blind treatment.
Overall study start date	01/01/2008
Completion date	30/10/2009

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. Aged between 18 and 75 years of age, both genders 2. Those who provide written informed consent 3. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for a primary diagnosis of schizophrenia 4. Not pregnant; if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study 5. Able and agrees to remain off prior antipsychotic medication for the duration of study 6. Good physical health on the basis of medical history, physical examination, and laboratory screening 7. 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/alcoholism or drug abuse/dependence within the last 6 months
Date of first enrolment	01/01/2008
Date of final enrolment	30/10/2009

Locations

Countries of recruitment

Bulgaria
Colombia
England
India
Lithuania
Peru
Philippines
Serbia
United Kingdom

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd

London
SE1E 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		14/02/2011		No	No

Editorial Notes

05/08/2021: Internal review.
20/07/2021: Internal review.
21/03/2016: added link to results - basic reporting.