Condition category
Mental and Behavioural Disorders
Date applied
14/11/2008
Date assigned
26/05/2009
Last edited
26/05/2009
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 Kaushik Sarma

ORCID ID

Contact details

Dainippon Sumitomo Pharma America Inc.
One Bridge Plaza
Suite 510
Fort Lee
New Jersey
07024
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D1050234

Study information

Scientific title

Acronym

PEARL 3 Extension Study

Study hypothesis

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long-term among schizophrenic outpatients with chronic schizophrenia.

Ethics approval

USA: Copernicus Group IRB, approved on 05/09/2008.

All other centres will seek ethics approval before recruitment of the first participant.

Study design

Randomised double-blind active comparator-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

Subjects who meet entry criteria will continue treatment with either flexibly dosed lurasidone or quetiapine XR based on their treatment assignment in Study D1050233 in a double-blinded fashion. Subjects treated with placebo in Study D1050233 will be treated with lurasidone.

Arm 1: Lurasidone HCI 40-160 mg/day orally for 12 months
Arm 2: Quetiapine XR 200-800 mg/day orally for 12 months

Intervention type

Drug

Phase

Phase III

Drug names

Lurasidone HCl, quetiapine XR

Primary outcome measures

1. Primary efficacy endpoint:
1.1. Time to relapse of psychotic symptoms in subjects to measure the long-term maintenance of antipsychotic efficacy of lurasidone compared with quetiapine XR.

2. Primary safety endpoints:
The proportion of subjects with:
2.1. Adverse Events (AEs)
2.2. Discontinuations due to AEs
2.3. Serious Adverse Events (SAEs)

AEs will be monitored throughout the study until Month 12.

Secondary outcome measures

Efficacy endpoints of interest:
Time to relapse of psychotic symptoms. Mean change from D1050233 baseline in the Positive and Negative Syndrome Scale (PANSS): positive score, negative score, and excitability score. PANSS will be carried out at Month 3, 6, 9, 12 in this extension study.

Overall trial start date

01/12/2008

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Principal inclusion criteria:
1. Males and females 18-75 years of age inclusive
2. Provide written informed consent
3. Completed all required assessments on the final study visit in Study D1050233
4. Suitable for treatment in an outpatient setting

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 240

Participant exclusion criteria

1. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
2. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property

Recruitment start date

01/12/2008

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Colombia, Germany, India, Philippines, Romania, Russian Federation, Ukraine, United States of America

Trial participating centre

Dainippon Sumitomo Pharma America Inc.
New Jersey
07024
United States of America

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

http://www.ds-pharma.co.jp/english

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

Publication citations

Additional files

Editorial Notes