Condition category
Mental and Behavioural Disorders
Date applied
26/02/2008
Date assigned
21/04/2008
Last edited
21/03/2016
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

Ms Shelda Alcock

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00615433

Protocol/serial number

D1050231

Study information

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

Acronym

Study hypothesis

Lurasidone HCl demonstrates greater efficiency, safety and tolerability in acutely psychotic patients with schizophrenia as compared with placebo.

Ethics approval

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

Study design

Randomised double-blind parallel-group study

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

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

Phase

Phase III

Drug names

Lurasidone, olanzapine

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

30/10/2009

Reason abandoned

Eligibility

Participant 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

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/alcoholism or drug abuse/dependence within the last 6 months

Recruitment start date

01/01/2008

Recruitment end date

30/10/2009

Locations

Countries of recruitment

Bulgaria, Colombia, India, Lithuania, Peru, Philippines, Serbia

Trial participating centre

Dainippon Sumitomo Pharma Europe Ltd
London
SE1E 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

Publication summary

See https://clinicaltrials.gov/ct2/show/results/NCT00615433

Publication citations

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.