Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
PEARL 3 Ext
A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)
1 other identifier
interventional
240
6 countries
65
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2008
Typical duration for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
August 21, 2012
CompletedJune 12, 2015
May 1, 2015
2.6 years
November 10, 2008
March 27, 2012
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse of Psychotic Symptoms
Time to relapse will be defined as the earliest occurrence of any of the following: * Worsening of \>= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale \>=3 * rehospitalization for worsening of psychosis * emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.
12 Months
Secondary Outcomes (3)
Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
Baseline and 6 Months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
Baseline and 12 months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
Baseline and 12 months
Study Arms (2)
Lurasidone HC1
EXPERIMENTALQuetiapine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Completed all required assessments on the final study visit in Study D1050233.
- Suitable for treatment in an outpatient setting.
You may not qualify if:
- Any chronic organic disease of the CNS (other than schizophrenia).
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
K&S Professional Research Services, LLC
Little Rock, Arkansas, 72201, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Comprehensive Neuroscience, Inc
Cerritos, California, 90703, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92647, United States
Synergy Escondido,710 East Grand Ave.
Escondido, California, 92025, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, 92645, United States
Apostle Clinical Trials, Inc.
Long Beach, California, 90813, United States
California Clinical Trials
Paramount, California, 90723, United States
Pasadena Research Institute
Pasadena, California, 91107, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, 90660, United States
CNRI- LOs Angeles, LLC
Pico Rivera, California, 90660, United States
Clinical Innovations, Inc.
Riverside, California, 92647, United States
CNRI - San Diego
San Diego, California, 92102, United States
UCSD Medical Drive
Sandeigo, California, 92103, United States
Segal Institute for Clinical Research
Highlands Ranch, Colorado, 80103, United States
Comprehensive Neuroscience, Inc.
Washington D.C., District of Columbia, 20016, United States
Florida Clinical Research Center LLC
Bradenton, Florida, 34208, United States
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana, 70601, United States
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301, United States
St. Louis Research, Inc.
St Louis, Missouri, 63118, United States
CRI Worldwide
Willingboro, New Jersey, 08046, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11238, United States
Comprehensive Neuroscience, Inc
Holliswood, New York, 11423, United States
Community Clinical Research
Austin, Texas, 78729, United States
FutureSearch Clinical Trials, LLC.
Austin, Texas, 78756, United States
Pillar Clinical Research
Dallas, Texas, 75243, United States
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Calle 80#47-43 Consultorio 5C, Barranquila S/N, Colombia
Centro de Investigacion y Atencion para la Salud Mental
Calle 103A # 21-49, Bogota S/N, Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, Colombia
Centro de Investigación y Atención para la Salud Mental
Bogotá, Colombia
CISNE - UIC Campo Abierto
Bogotá, Colombia
Instituto Colombiano del Sistema Nervioso Clínica Montserrat
Bogotá, Colombia
S.V. Medical College
Tirupati, Andhra Pradesh, 517507, India
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, 520002, India
Shanti Nursing Home
Kanchanpalli, Aurangabad, Maharashtra, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006, India
SBKS Medical College and Hospital, Brij Psychiatry Hospital
Vadodara, Gujarat, 390001, India
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, 574160, India
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, 570004, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004, India
Mahatma Gandhi Institute of Medical Sciences
Sewāgrām, Maharashtra, India
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003, India
Spitalul Clinic Judetean de Urgenta Arad
Str. Octavian Goga Nr. 17, Arad, 310022, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Sos. Berceni Nr. 10-12, București, 041914, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, Romania
Spitalul Judetean Arges
Piteşti, 110069, Romania
Andreev, Boris
Gatchina, Russia
Gurovich, Isaak
Moscow, Russia
Morozova, Margarita
Moscow, Russia
City Psychoneurological Dispensary #7 (with Hospital)
Saint Petersburg, 190005, Russia
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, 190121, Russia
City Psychiatric Hospital #4
Saint Petersburg, 191119, Russia
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg, 197341, Russia
Neznanov, Nikolay
Saint Petersburg, Russia
Sheifer, Mikhail
Samara, Russia
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005, Ukraine
Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
Donetsk, 83037, Ukraine
Kyiv City Clin. Psychoneurolog. Hosp.#1
Kyiv, 04080, Ukraine
Kyiv City Psychoneurological Hospital
Kyviv, Ukraine
Lviv Reg.St.Cl.Psych.Hosp
Lviv, Ukraine
Reg. Psychiatric Hospital
Odesa, Ukraine
Crimean republican Clinical Psychiatric Hospital
Simferopol, Ukraine
Kherson Regional Psychiatric Hospital
Vil. Stepanovka, Kherson, 73488, Ukraine
Related Publications (3)
Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013 Jun;147(1):95-102. doi: 10.1016/j.schres.2013.03.013. Epub 2013 Apr 11.
PMID: 23583011RESULTHarvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
PMID: 24035633RESULTHarvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.
PMID: 26117157DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, CNS
- Organization
- Sunovion Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 13, 2008
Study Start
December 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
June 12, 2015
Results First Posted
August 21, 2012
Record last verified: 2015-05