Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
PEARL 3
A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)
1 other identifier
interventional
488
5 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 short term among acutely psychotic patients with chronic schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Oct 2008
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
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
October 6, 2011
CompletedMarch 17, 2016
March 1, 2016
1.7 years
November 10, 2008
September 1, 2011
March 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Week 6
Secondary Outcomes (1)
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
6-Weeks
Study Arms (4)
Lurasidone 80mg
EXPERIMENTALLurasidone 160mg
EXPERIMENTALQuetiapine XR
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
You may not qualify if:
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Any chronic organic disease of the CNS (other than schizophrenia).
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
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
Clinical Pharmacological Studies, Inc.
Cerritos, California, 90703, United States
Comprehensive Neuroscience, Inc
Cerritos, California, 90703, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92647, United States
Synergy Escondido
Escondido, California, 92025, United States
Collaborative Neuroscience Network
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
Pico Rivera, California, 90660, United States
Clinical Innovations, Inc.
Riverside, California, 92647, United States
CNRI-San Diego
San Diego, California, 92126, United States
UCSD Medical Center
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
Bradenton, Florida, 34208, United States
Florida Clinical Research Center, LLC
Fruitland Park, Florida, 34731, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601, United States
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104, United States
Precise Clinical Research
Flowood, Mississippi, 39232, 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
Comprehensive Neuroscience, Inc
Holliswood, New York, 11423, United States
Segal Institute for Clinical Research
Winston-Salem, North Carolina, 27104, United States
Community Clinical Research
Austin, Texas, 78729, United States
Future Search Trials of Neurology
Austin, Texas, 78756, United States
Pillar Clinical Research
Dallas, Texas, 75243, United States
S.V. Medical College
Tirupati, Andhra Pradesh, 517507, India
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, 520002, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006, India
SBKS Medical Institute and Research Centre
Vadodara, Gujarat, 391760, India
Justice K.S. Hegde Charitable Hospital
Mangalore, Karnataka, 574160, India
JSS Medical College and Hospital
Mysore, Karnataka, 570004, India
Shanti Nursing Home
Aurangabad, Maharashtra, 431005, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004, India
Mahatma Gandhi Institute of Medical Sciences
Sewāgrām, Maharashtra, 442102, 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 de Psihiatrie Titan "Dr. Constantin Gorgos"
Bdul Nicolae Grigorescu Nr. 41, București, 030440, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Sos. Berceni Nr. 10-12, București, 041914, Romania
Spitalul Judetean Arges
Str. Negru Voda Nr. 53, Pitesti, 110069, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, Romania
SEI of H.P. Educat. Northern SMU
Arkhangelsk, 163060, Russia
St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko
Gatchina, 188357, Russia
Moscow Scientific Research Institute of Psychiatry
Moscow, 107076, Russia
Institution of RAMS Mental Health Research Center of RAMS
Moscow, 115522, Russia
City Clinical Psichiatric Hospital #1
Nizhny Novgorod, 603 155, Russia
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, Russia
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg, Russia
City Psychiatric Hospital #4
Saint Petersburg, Russia
SHI City Psychoneurological Dispensary #7
Saint Petersburg, Russia
St. Petersburg GUZ City Psychiatric Hospital #6
Saint Petersburg, Russia
SHI Samara Psychiatric Hospital
Samara, 443016, Russia
Kherson Regional Psychiatric Hospital
Kherson,vil., Stepanovka, 73488, Ukraine
RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology
Dnipropetrovsk, 49005, Ukraine
Chair of Psychiatry and Medical Psychology
Donetsk, 83008, Ukraine
Centre of Novel Treatment and Rehabilitation of Psychotic disorders
Kyiv, Ukraine
Kyiv City Psychoneurological Hospital
Kyviv, Ukraine
Lviv Reg.St.Cl.Psych.Hosp
Lviv, Ukraine
Reg. Psychiatric Hospital
Odesa, Ukraine
Poltava Regional Clinical Psychiatric Hospital,
Poltava, Ukraine
Crimean republican Clinical Psychiatric Hospital
Simferopol, Ukraine
Related Publications (7)
Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.
PMID: 23415311RESULTHarvey 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: 24035633RESULTLoebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. doi: 10.1017/S1092852913000904. Epub 2013 Dec 13.
PMID: 24330860RESULTHopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
PMID: 39144777DERIVEDHopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
PMID: 34751928DERIVEDHarvey 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: 26117157DERIVEDNasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
PMID: 24955752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro, PhD, Executive Director
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
October 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
March 17, 2016
Results First Posted
October 6, 2011
Record last verified: 2016-03