Condition category
Mental and Behavioural Disorders
Date applied
06/02/2008
Date assigned
21/04/2008
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shelda Alcock

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00549718

Protocol/serial number

D1050229

Study information

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

Acronym

Study hypothesis

Lurasidone HCI demonstrates greater efficacy, safety and tolerability in acutely psychotic patients with schizophrenia as compared to placebo.

Ethics approval

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Phase III

Drug names

Lurasidone hydrochloride (HCl)

Primary outcome measures

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 trial start date

01/11/2007

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 480 patients

Participant 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

Recruitment start date

01/11/2007

Recruitment end date

31/07/2011

Locations

Countries of recruitment

France, India, Malaysia, Romania, Russian Federation, Ukraine, United States of America

Trial participating centre

Dainippon Sumitomo Pharma Europe Ltd (Europe)
London
SW1E 6QT
United Kingdom

Sponsor information

Organisation

Dainippon Sumitomo Pharma America Inc. (USA)

Sponsor details

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

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Dainippon Sumitomo Pharma Co Ltd (Japan)

Alternative name(s)

Dainippon Sumitomo Pharma Co., Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Japan

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00549718

Publication summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23421963

Publication citations

Additional files

Editorial Notes

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