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Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia (PEARL 3 Ext)

Primary Purpose

Chronic Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurasidone HC1
Quetiapine XR
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Schizophrenia focused on measuring Schizophrenia, SM-13496, Latuda, Lurasidone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • K&S Professional Research Services, LLC
  • Woodland International Research Group
  • Comprehensive Neuroscience, Inc
  • Clinical Innovations, Inc.
  • Synergy Escondido,710 East Grand Ave.
  • Collaborative Neuroscience Network Inc
  • Apostle Clinical Trials, Inc.
  • California Clinical Trials
  • Pasadena Research Institute
  • CNRI - Los Angeles LLC,8309 Telegraph Road
  • CNRI- LOs Angeles, LLC
  • Clinical Innovations, Inc.
  • CNRI - San Diego
  • UCSD Medical Drive
  • Segal Institute for Clinical Research
  • Comprehensive Neuroscience, Inc.
  • Florida Clinical Research Center LLC
  • Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
  • Booker, J. Gary, MD. APMC
  • St. Charles Psychiatric Associates
  • St. Louis Research, Inc.
  • CRI Worldwide
  • SUNY Downstate Medical Center
  • Comprehensive Neuroscience, Inc
  • Community Clinical Research
  • FutureSearch Clinical Trials, LLC.
  • Pillar Clinical Research
  • CIPNA Centro de Investigaciones y Proyectos en Neurociencias
  • Centro de Investigacion y Atencion para la Salud Mental
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  • Centro de Investigación y Atención para la Salud Mental
  • CISNE - UIC Campo Abierto
  • Instituto Colombiano del Sistema Nervioso Clínica Montserrat
  • Vijayawada Institute of Mental Health and Neurosciences
  • S.V. Medical College
  • Shanti Nursing Home
  • Seth K M School of P G Medicine & Research
  • SBKS Medical College and Hospital, Brij Psychiatry Hospital
  • Justice K.S. Hedge Charitable Hospital
  • JSS Medical College and Hospital - Dept of Psychiatry
  • Mahatma Gandhi Institute of Medical Sciences
  • Deenanath Mangeshkar Hospital and Research Centre
  • Madras Medical College & Government General Hospital
  • Spitalul Clinic Judetean de Urgenta Arad
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
  • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • Spitalul Judetean Arges
  • Andreev, Boris
  • Gurovich, Isaak
  • Morozova, Margarita
  • Sheifer, Mikhail
  • City Psychoneurological Dispensary #7 (with Hospital)
  • City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
  • City Psychiatric Hospital #4
  • City Psychiatric Hospital #3 of Skvortsov-Stepanov
  • Neznanov, Nikolay
  • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
  • Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
  • Kyiv City Clin. Psychoneurolog. Hosp.#1
  • Kyiv City Psychoneurological Hospital
  • Lviv Reg.St.Cl.Psych.Hosp
  • Reg. Psychiatric Hospital
  • Crimean republican Clinical Psychiatric Hospital
  • Kherson Regional Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lurasidone HC1

Quetiapine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
November 10, 2008
Last Updated
May 19, 2015
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00789698
Brief Title
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Schizophrenia
Keywords
Schizophrenia, SM-13496, Latuda, Lurasidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone HC1
Arm Type
Experimental
Arm Title
Quetiapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone HC1
Intervention Description
Lurasidone 40-160 mg/day flexibly dosed.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Intervention Description
Quetiapine XR 200-800 mg/day flexibly dosed.
Primary Outcome Measure Information:
Title
Relapse of Psychotic Symptoms
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
Description
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.
Time Frame
Baseline and 6 Months
Title
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
Description
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).
Time Frame
Baseline and 12 months
Title
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
Description
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.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
K&S Professional Research Services, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Comprehensive Neuroscience, Inc
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Synergy Escondido,710 East Grand Ave.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuroscience Network Inc
City
Garden Grove
State/Province
California
ZIP/Postal Code
92645
Country
United States
Facility Name
Apostle Clinical Trials, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
California Clinical Trials
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pasadena Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
CNRI - Los Angeles LLC,8309 Telegraph Road
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
CNRI- LOs Angeles, LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
CNRI - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
UCSD Medical Drive
City
Sandeigo
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Segal Institute for Clinical Research
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80103
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Florida Clinical Research Center LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Booker, J. Gary, MD. APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
St. Charles Psychiatric Associates
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
St. Louis Research, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
CRI Worldwide
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11238
Country
United States
Facility Name
Comprehensive Neuroscience, Inc
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78729
Country
United States
Facility Name
FutureSearch Clinical Trials, LLC.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Pillar Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
City
Calle 80#47-43 Consultorio 5C
State/Province
Barranquila S/N
Country
Colombia
Facility Name
Centro de Investigacion y Atencion para la Salud Mental
City
Calle 103A # 21-49
State/Province
Bogota S/N
Country
Colombia
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
City
Barranquilla
Country
Colombia
Facility Name
Centro de Investigación y Atención para la Salud Mental
City
Bogota
Country
Colombia
Facility Name
CISNE - UIC Campo Abierto
City
Bogota
Country
Colombia
Facility Name
Instituto Colombiano del Sistema Nervioso Clínica Montserrat
City
Bogota
Country
Colombia
Facility Name
Vijayawada Institute of Mental Health and Neurosciences
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
S.V. Medical College
City
Tirupati
State/Province
Andra Pradesh
ZIP/Postal Code
517507
Country
India
Facility Name
Shanti Nursing Home
City
Kanchanpalli
State/Province
Aurangabad, Maharashtra
Country
India
Facility Name
Seth K M School of P G Medicine & Research
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
SBKS Medical College and Hospital, Brij Psychiatry Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Justice K.S. Hedge Charitable Hospital
City
Mangalore
State/Province
Karna
ZIP/Postal Code
574160
Country
India
Facility Name
JSS Medical College and Hospital - Dept of Psychiatry
City
Mysore
State/Province
Karna
ZIP/Postal Code
570004
Country
India
Facility Name
Mahatma Gandhi Institute of Medical Sciences
City
Sewagram
State/Province
Maharashtra
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharastra
ZIP/Postal Code
411004
Country
India
Facility Name
Madras Medical College & Government General Hospital
City
Chennai
State/Province
TamilNadu
ZIP/Postal Code
600003
Country
India
Facility Name
Spitalul Clinic Judetean de Urgenta Arad
City
Str. Octavian Goga nr. 17
State/Province
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
City
Sos. Berceni nr. 10-12
State/Province
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic de Neurologie si Psihiatrie Oradea
City
Oradea
Country
Romania
Facility Name
Spitalul Judetean Arges
City
Pitesti
ZIP/Postal Code
110069
Country
Romania
Facility Name
Andreev, Boris
City
Gatchina
Country
Russian Federation
Facility Name
Gurovich, Isaak
City
Moscow
Country
Russian Federation
Facility Name
Morozova, Margarita
City
Moscow
Country
Russian Federation
Facility Name
Sheifer, Mikhail
City
Samara
Country
Russian Federation
Facility Name
City Psychoneurological Dispensary #7 (with Hospital)
City
St-Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
City Psychiatric Hospital #4
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
City Psychiatric Hospital #3 of Skvortsov-Stepanov
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Neznanov, Nikolay
City
St. Petersburg
Country
Russian Federation
Facility Name
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Kyiv City Clin. Psychoneurolog. Hosp.#1
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Kyiv City Psychoneurological Hospital
City
Kyviv
Country
Ukraine
Facility Name
Lviv Reg.St.Cl.Psych.Hosp
City
Lviv
Country
Ukraine
Facility Name
Reg. Psychiatric Hospital
City
Odessa
Country
Ukraine
Facility Name
Crimean republican Clinical Psychiatric Hospital
City
Simferopol
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital
City
vil. Stepanovka, Kherson
ZIP/Postal Code
73488
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
23583011
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.
Results Reference
result
PubMed Identifier
24035633
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.
Results Reference
result
PubMed Identifier
26117157
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.
Results Reference
derived

Learn more about this trial

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

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