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

ISRCTN	ISRCTN44297014
DOI	https://doi.org/10.1186/ISRCTN44297014
Protocol serial number	D1050234
Sponsor	Dainippon Sumitomo Pharma America Inc. (USA)
Funder	Dainippon Sumitomo Pharma Co. Ltd. (Japan)

Submission date: 14/11/2008
Registration date: 26/05/2009
Last edited: 26/05/2009

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kaushik Sarma
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised double-blind active comparator-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PEARL 3 Extension Study
Study objectives	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(s)	USA: Copernicus Group IRB, approved on 05/09/2008. All other centres will seek ethics approval before recruitment of the first participant.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Lurasidone HCl, quetiapine XR
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

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

Study participating centre

Dainippon Sumitomo Pharma America Inc.

New Jersey
07024
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes