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
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