Clinical trial NCT00789698: Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Schizophrenia
Keywords: Schizophrenia
SM-13496
Latuda
Lurasidone
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 240
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 long term among schizophrenic outpatients with chronic schizophrenia.


Eligibility criteria: Entry Criteria:

* Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Inclusion Criteria:

* Completed all required assessments on the final study visit in Study D1050233.
* Suitable for treatment in an outpatient setting.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Relapse of Psychotic Symptoms
timeFrame: 12 Months
Secondary outcomes:
measure: Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
timeFrame: Baseline and 6 Months
measure: Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and 12 months
measure: 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
timeFrame: Baseline and 12 months
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: 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,710 East Grand Ave.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc
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,8309 Telegraph Road
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 Drive
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 LLC
state: Florida
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
state: Louisiana
city: Shreveport
country: United States
facility: Booker, J. Gary, MD. APMC
state: Louisiana
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: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Holliswood
country: United States
facility: Comprehensive Neuroscience, Inc
state: New York
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LLC.
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research
state: Texas
city: Calle 80#47-43 Consultorio 5C
country: Colombia
facility: CIPNA Centro de Investigaciones y Proyectos en Neurociencias
state: Barranquila S/N
city: Calle 103A # 21-49
country: Colombia
facility: Centro de Investigacion y Atencion para la Salud Mental
state: Bogota S/N
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA
city: Bogota
country: Colombia
facility: Centro de Investigación y Atención para la Salud Mental
city: Bogota
country: Colombia
facility: CISNE - UIC Campo Abierto
city: Bogota
country: Colombia
facility: Instituto Colombiano del Sistema Nervioso Clínica Montserrat
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: Kanchanpalli
country: India
facility: Shanti Nursing Home
state: Aurangabad, Maharashtra
city: Ahmedabad
country: India
facility: Seth K M School of P G Medicine & Research
state: Gujarat
city: Vadodara
country: India
facility: SBKS Medical College and Hospital, Brij Psychiatry Hospital
state: Gujarat
city: Mangalore
country: India
facility: Justice K.S. Hedge Charitable Hospital
state: Karna
city: Mysore
country: India
facility: JSS Medical College and Hospital - Dept of Psychiatry
state: Karna
city: Sewagram
country: India
facility: Mahatma Gandhi Institute of Medical Sciences
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
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: Sos. Berceni nr. 10-12
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
state: Bucuresti
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: Pitesti
country: Romania
facility: Spitalul Judetean Arges
city: Gatchina
country: Russian Federation
facility: Andreev, Boris
city: Moscow
country: Russian Federation
facility: Gurovich, Isaak
city: Moscow
country: Russian Federation
facility: Morozova, Margarita
city: Samara
country: Russian Federation
facility: Sheifer, Mikhail
city: St-Petersburg
country: Russian Federation
facility: City Psychoneurological Dispensary #7 (with Hospital)
city: St. Petersburg
country: Russian Federation
facility: City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #4
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov
city: St. Petersburg
country: Russian Federation
facility: Neznanov, Nikolay
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov
city: Donetsk
country: Ukraine
facility: Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
city: Kyiv
country: Ukraine
facility: Kyiv City Clin. Psychoneurolog. Hosp.#1
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: Simferopol
country: Ukraine
facility: Crimean republican Clinical Psychiatric Hospital
city: vil. Stepanovka, Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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: 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.