Clinical trial NCT00790192: Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
SM-13496
Latuda
Lurasidone
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
timeFrame: Week 6
Secondary outcomes:
measure: Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
timeFrame: 6-Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K&S Professional Research Services, LLC
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Cerritos
country: United States
facility: Clinical Pharmacological Studies, Inc.
state: California
city: Cerritos
country: United States
facility: Comprehensive Neuroscience, Inc
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Escondido
country: United States
facility: Synergy Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Long Beach
country: United States
facility: Apostle Clinical Trials, Inc.
state: California
city: Paramount
country: United States
facility: California Clinical Trials
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute
state: California
city: Pico Rivera
country: United States
facility: CNRI-Los Angeles. LLC
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: CNRI-San Diego
state: California
city: Sandeigo
country: United States
facility: UCSD Medical Center
state: California
city: Highlands Ranch
country: United States
facility: Segal Institute for Clinical Research
state: Colorado
city: Washington
country: United States
facility: Comprehensive Neuroscience, Inc.
state: District of Columbia
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Fruitland Park
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Shreveport
country: United States
facility: Booker, J. Gary, MD. APMC
state: Louisiana
city: Flowood
country: United States
facility: Precise Clinical Research
state: Mississippi
city: St Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Research, Inc.
state: Missouri
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
city: Holliswood
country: United States
facility: Comprehensive Neuroscience, Inc
state: New York
city: Winston-Salem
country: United States
facility: Segal Institute for Clinical Research
state: North Carolina
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Austin
country: United States
facility: Future Search Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research
state: Texas
city: Vijayawada
country: India
facility: Vijayawada Institute of Mental Health and Neurosciences
state: Andhra Pradesh
city: Tirupati
country: India
facility: S.V. Medical College
state: Andra Pradesh
city: Ahmedabad
country: India
facility: Seth K M School of P G Medicine & Research
state: Gujarat
city: Vadodara
country: India
facility: SBKS Medical Institute and Research Centre
state: Gujarat
city: Mangalore
country: India
facility: Justice K.S. Hegde Charitable Hospital
state: Karnataka
city: Mysore
country: India
facility: JSS Medical College and Hospital
state: Karnataka
city: Aurangabad
country: India
facility: Shanti Nursing Home
state: Maharastra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharastra
city: Sewagram
country: India
facility: Mahatma Gandhi Institute of Medical Sciences
state: Maharastra
city: Chennai
country: India
facility: Madras Medical College & Government General Hospital
state: TamilNadu
city: Str. Octavian Goga nr. 17
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Arad
state: Arad
city: Bdul Nicolae Grigorescu nr. 41
country: Romania
facility: Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
state: Bucuresti
city: Sos. Berceni nr. 10-12
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
state: Bucuresti
city: Str. Negru Voda nr. 53
country: Romania
facility: Spitalul Judetean Arges
state: Pitesti
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
city: Oradea
country: Romania
facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea
city: Arkhangelsk
country: Russian Federation
facility: SEI of H.P. Educat. Northern SMU
city: Gatchina
country: Russian Federation
facility: St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Institute of Psychiatry
city: Moscow
country: Russian Federation
facility: Institution of RAMS Mental Health Research Center of RAMS
city: Nizhniy Novgorod
country: Russian Federation
facility: City Clinical Psichiatric Hospital #1
city: Samara
country: Russian Federation
facility: SHI Samara Psychiatric Hospital
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #4
city: St. Petersburg
country: Russian Federation
facility: SHI City Psychoneurological Dispensary #7
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg GUZ City Psychiatric Hospital #6
city: Kherson,vil.
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
state: Stepanovka
city: Dnipropetrovsk
country: Ukraine
facility: RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology
city: Donetsk
country: Ukraine
facility: Chair of Psychiatry and Medical Psychology
city: Kyiv
country: Ukraine
facility: Centre of Novel Treatment and Rehabilitation of Psychotic disorders
city: Kyviv
country: Ukraine
facility: Kyiv City Psychoneurological Hospital
city: Lviv
country: Ukraine
facility: Lviv Reg.St.Cl.Psych.Hosp
city: Odessa
country: Ukraine
facility: Reg. Psychiatric Hospital
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Psychiatric Hospital,
city: Simferopol
country: Ukraine
facility: Crimean republican Clinical Psychiatric Hospital
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Harvey 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.
citation: Loebel 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.
citation: Hopkins 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.
citation: Harvey 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.
citation: Nasrallah 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.