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

NCT00790192

Protocol/serial number

D1050233

Study information

Scientific title

A phase III randomised, double-blind, placebo- and active comparator-controlled clinical trial to study the safety and efficacy of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)

Acronym

PEARL 3

Study hypothesis

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. The clinical study is designed to test the hypothesis that lurasidone is effective, tolerable and safe as compared with quetiapine XR short-term among acutely psychotic patients 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 placebo- and 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

There is a 14-day screening period and a 3 to 7-day placebo washout period before randomisation of the participants for the trial.

Patients will be randomly assigned to one of the four treatment arms in equal numbers:
Arm 1: Lurasidone HCI 80 mg/day orally for 6 weeks
Arm 2: Lurasidone HCl 160 mg/day orally for 6 weeks
Arm 3: Quetiapine XR 600 mg/day for 6 weeks
Arm 4: Placebo for 6 weeks

Intervention type

Drug

Phase

Phase III

Drug names

Lurasidone, quetiapine

Primary outcome measures

Primary Efficacy Endpoint:
Mean change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (Week 6).

Primary Safety Endpoints:
The proportion of subjects with the following at Week 6:
1. Adverse Events (AEs)
2. Discontinuations due to AEs
3. Serious Adverse Events (SAEs)

Secondary outcome measures

Key secondary efficacy endpoints:
Mean change from baseline in:
1. Clinical Global Impressions Severity (CGI-S) score, assessed at baseline, Day 4, then every week until Week 6
2. PANSS total score, assessed at baseline, Day 4, then every week until Week 6

Overall trial start date

15/10/2008

Overall trial end date

12/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Provide written informed consent and aged between 18 and 75 years of age (both males and females are eligible)
2. Meets 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

480

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

15/10/2008

Recruitment end date

12/12/2009

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

See https://clinicaltrials.gov/ct2/show/results/NCT00790192

Publication summary

Publication citations

Additional files

Editorial Notes

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