Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

Chronic Schizophrenia Clinical Trial

— PEARL 3 Ext  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789698
• Other study ID #: D1050234
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2008
• Last updated: May 19, 2015
• Start date: December 2008
• Est. completion date: July 2011

Study information

• Verified date: May 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationColombia: Ministry of HealthIndia: Drugs Controller General of IndiaRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

Intervention

Drug:
• Lurasidone HC1
Lurasidone 40-160 mg/day flexibly dosed.
• Quetiapine XR
Quetiapine XR 200-800 mg/day flexibly dosed.

Locations

Country	Name	City	State
Colombia	Centro de Investigaciones y Proyectos en Neurociencias CIPNA	Barranquilla
Colombia	Centro de Investigación y Atención para la Salud Mental	Bogota
Colombia	CISNE - UIC Campo Abierto	Bogota
Colombia	Instituto Colombiano del Sistema Nervioso Clínica Montserrat	Bogota
Colombia	Centro de Investigacion y Atencion para la Salud Mental	Calle 103A # 21-49	Bogota S/N
Colombia	CIPNA Centro de Investigaciones y Proyectos en Neurociencias	Calle 80#47-43 Consultorio 5C	Barranquila S/N
India	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat
India	Madras Medical College & Government General Hospital	Chennai	TamilNadu
India	Shanti Nursing Home	Kanchanpalli	Aurangabad, Maharashtra
India	Justice K.S. Hedge Charitable Hospital	Mangalore	Karna
India	JSS Medical College and Hospital - Dept of Psychiatry	Mysore	Karna
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharastra
India	Mahatma Gandhi Institute of Medical Sciences	Sewagram	Maharashtra
India	S.V. Medical College	Tirupati	Andra Pradesh
India	SBKS Medical College and Hospital, Brij Psychiatry Hospital	Vadodara	Gujarat
India	Vijayawada Institute of Mental Health and Neurosciences	Vijayawada	Andhra Pradesh
Romania	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia	Bucuresti
Romania	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea
Romania	Spitalul Judetean Arges	Pitesti
Romania	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia	Sos. Berceni nr. 10-12	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Arad	Str. Octavian Goga nr. 17	Arad
Russian Federation	Andreev, Boris	Gatchina
Russian Federation	Gurovich, Isaak	Moscow
Russian Federation	Morozova, Margarita	Moscow
Russian Federation	Sheifer, Mikhail	Samara
Russian Federation	City Psychoneurological Dispensary #7 (with Hospital)	St-Petersburg
Russian Federation	City Psychiatric Hospital #3 of Skvortsov-Stepanov	St. Petersburg
Russian Federation	City Psychiatric Hospital #4	St. Petersburg
Russian Federation	City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets	St. Petersburg
Russian Federation	Neznanov, Nikolay	St. Petersburg
Ukraine	Dnipropetrovsk Regional Clinical Hospital named Mechnikov	Dnipropetrovsk
Ukraine	Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy	Donetsk
Ukraine	Kyiv City Clin. Psychoneurolog. Hosp.#1	Kyiv
Ukraine	Kyiv City Psychoneurological Hospital	Kyviv
Ukraine	Lviv Reg.St.Cl.Psych.Hosp	Lviv
Ukraine	Reg. Psychiatric Hospital	Odessa
Ukraine	Crimean republican Clinical Psychiatric Hospital	Simferopol
Ukraine	Kherson Regional Psychiatric Hospital	vil. Stepanovka, Kherson
United States	Community Clinical Research	Austin	Texas
United States	FutureSearch Clinical Trials, LLC.	Austin	Texas
United States	Florida Clinical Research Center LLC	Bradenton	Florida
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Comprehensive Neuroscience, Inc	Cerritos	California
United States	Clinical Innovations, Inc.	Costa Mesa	California
United States	Pillar Clinical Research	Dallas	Texas
United States	Synergy Escondido,710 East Grand Ave.	Escondido	California
United States	Collaborative Neuroscience Network Inc	Garden Grove	California
United States	Segal Institute for Clinical Research	Highlands Ranch	Colorado
United States	Comprehensive Neuroscience, Inc	Holliswood	New York
United States	Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340	Lake Charles	Louisiana
United States	K&S Professional Research Services, LLC	Little Rock	Arkansas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Apostle Clinical Trials, Inc.	Long Beach	California
United States	California Clinical Trials	Paramount	California
United States	Pasadena Research Institute	Pasadena	California
United States	CNRI - Los Angeles LLC,8309 Telegraph Road	Pico Rivera	California
United States	CNRI- LOs Angeles, LLC	Pico Rivera	California
United States	Clinical Innovations, Inc.	Riverside	California
United States	CNRI - San Diego	San Diego	California
United States	UCSD Medical Drive	Sandeigo	California
United States	Booker, J. Gary, MD. APMC	Shreveport	Louisiana
United States	St. Charles Psychiatric Associates	St. Charles	Missouri
United States	St. Louis Research, Inc.	St. Louis	Missouri
United States	Comprehensive Neuroscience, Inc.	Washington	District of Columbia
United States	CRI Worldwide	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Colombia,  India,  Romania,  Russian Federation,  Ukraine, 

References & Publications (2)

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 Neuropsychoph — View 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.	The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.	Baseline and 6 Months	No
Secondary	Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)	The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).	Baseline and 12 months	No
Secondary	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	The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.	Baseline and 12 months	No