Safety and efficacy trial of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)

ISRCTN	ISRCTN64695913
DOI	https://doi.org/10.1186/ISRCTN64695913
ClinicalTrials.gov (NCT)	NCT00790192
Protocol serial number	D1050233
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: 10/04/2019

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

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 placebo- and active comparator-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study acronym	PEARL 3
Study objectives	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(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	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 / device / biological / vaccine name(s)	Lurasidone, quetiapine
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	12/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	480
Key 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
Key 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
Date of first enrolment	15/10/2008
Date of final enrolment	12/12/2009

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?
Results article	results	01/11/2013	10/04/2019	Yes	No
Results article	results	01/08/2015	10/04/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/04/2019: Publication reference added.
22/03/2016: added link to results - basic reporting.