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Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

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

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Lurasidone, Schizophrenia, Latuda

Eligibility Criteria

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

Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

  • Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
  • Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
  • Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
  • Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

  • Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
  • Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
  • In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
  • Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Sites / Locations

  • K&S Professional Research Services LLC
  • Woodland International Research Group, LLC
  • South Coast Clinical Trials, Inc.
  • Comprehensive NeuroScience, Inc. - Cerritos
  • Clinical Innovations Inc.
  • Collaborative Neuroscience Network Inc
  • University of Southern California
  • Excell Research
  • University of California at Irvine Medical Center
  • Pasadena Research Institute
  • CNRI-Los Angeles, LLC
  • Clinical Innovations Inc.
  • CNRI-San Diego LLC
  • UCSD, Outpatient Psychiatric Services
  • Clinical Innovations Inc.
  • Collaborative Neuroscience Network Inc
  • Comprehensive NeuroScience, Inc.
  • Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
  • Fidelity Clinical Research Inc.
  • Atlanta Center for Medical Research
  • Northlake Medical Research Center
  • Alexian Brothers Medical Center
  • Lake Charles Clinical Trials
  • Sheppard Pratt Health System
  • Precise Research Center
  • St. Charles Psychiatric Associates - Midwest Research
  • St. Louis Clinical Trials
  • Creighton University
  • CRI Worldwide
  • SUNY Downstate University
  • Neurobehavioral Research Inc.
  • Manhattan Psychiatric Center
  • Social Psychiatry Research Institute
  • University of North Carolina at Chapel Hill
  • Keystone Clinical Studies, LLC
  • CRI Worldwide
  • Research Strategies of Memphis LLC
  • Community Clinical Research, Inc.
  • Pillar Clinical Research LLC
  • Claghorn-Lesem Research Clinic, Inc.
  • Alliance Research Group
  • Fundación para el Estudio y Tratamiento de las Enf. Mentales
  • Clinica Privada Neuropsiquiatrica San Agustin
  • Resolution Psychopharmacology Research Institute
  • CIAP
  • Sanatorio 'Prof. Leon S. Morra' S.A.
  • Sanatorio Sao Paulo
  • Hospital Espirita de Psiquiatria Bom Retiro
  • Hospital Mario Kroeff
  • PAX Clinica Psiquiatrica Ltda
  • Hospital Clincio Felix Bulnes
  • Instituto Psiquiátrico Dr. José Horwitz Barak
  • Hospital Barros Luco Trudeau
  • CIPAM - Clínica Pedro Montt
  • Hospital Base Valdivia
  • Clinical Hospital Centre Rijeka
  • Psychiatric Hospital Vrapce
  • Croatian institute for brain research Neuron
  • Beer Ya'acov Mental Health Center
  • Rambam Health Care Campus
  • Shalvata Mental Health Center, Ward B
  • Shalvata Mental Health Center
  • Chaim Sheba Medical Center
  • Oranje Hospital
  • Rand Clinic
  • Private Practice
  • Flexivest fourteen Research Centre
  • Cape Trial Centre
  • Crompton Medical Centre East
  • Weskoppies Hospital
  • King Chulalongkorn Memorial Hospital
  • Somdet Chaopraya Institute of Psychiatry
  • Suan Prung Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Lurasidone

Risperidone

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2008
Last Updated
June 16, 2015
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00641745
Brief Title
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Official Title
Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (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 safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Lurasidone, Schizophrenia, Latuda

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lurasidone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Risperidone
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCl
Intervention Description
40 - 120mg per day
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Risperidone
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events.
Time Frame
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
Main Inclusion Criteria: To be eligible to enter the study, each patient must comply with the following inclusion criteria: Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment). Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes. Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study. Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator. Subject voluntarily agrees to participate in the study by giving written informed consent. Main Exclusion Criteria: To be excluded from entering this study if they fulfil any of the criteria below: Subject has a chronic organic disease of the central nervous system (other than schizophrenia). Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study. Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
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, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
South Coast Clinical Trials, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Comprehensive NeuroScience, Inc. - Cerritos
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
92626
Country
United States
Facility Name
Collaborative Neuroscience Network Inc
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California at Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
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
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
92506
Country
United States
Facility Name
CNRI-San Diego LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
UCSD, Outpatient Psychiatric Services
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Innovations Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Collaborative Neuroscience Network Inc
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Comprehensive NeuroScience, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Fidelity Clinical Research Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northlake Medical Research Center
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Precise Research Center
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
St. Louis Clinical Trials
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CRI Worldwide
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
SUNY Downstate University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Neurobehavioral Research Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Social Psychiatry Research Institute
City
New York
State/Province
New York
ZIP/Postal Code
10454
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
CRI Worldwide
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Research Strategies of Memphis LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Pillar Clinical Research LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Alliance Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Fundación para el Estudio y Tratamiento de las Enf. Mentales
City
Capital Federal
State/Province
BUE
ZIP/Postal Code
C1425AHP
Country
Argentina
Facility Name
Clinica Privada Neuropsiquiatrica San Agustin
City
La Plata
State/Province
BUE
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Resolution Psychopharmacology Research Institute
City
Mendoza
State/Province
MEN
ZIP/Postal Code
M5502HLE
Country
Argentina
Facility Name
CIAP
City
Rosario
State/Province
SFE
ZIP/Postal Code
S2000QJI
Country
Argentina
Facility Name
Sanatorio 'Prof. Leon S. Morra' S.A.
City
Cordoba
ZIP/Postal Code
X5009BIN
Country
Argentina
Facility Name
Sanatorio Sao Paulo
City
Salvador
State/Province
BA
ZIP/Postal Code
40301-500
Country
Brazil
Facility Name
Hospital Espirita de Psiquiatria Bom Retiro
City
Curitiba
State/Province
PR
ZIP/Postal Code
80520-000
Country
Brazil
Facility Name
Hospital Mario Kroeff
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21020-130
Country
Brazil
Facility Name
PAX Clinica Psiquiatrica Ltda
City
Aparecida de Goiania
ZIP/Postal Code
74922-810
Country
Brazil
Facility Name
Hospital Clincio Felix Bulnes
City
Quinta Normal
State/Province
Santiago
Country
Chile
Facility Name
Instituto Psiquiátrico Dr. José Horwitz Barak
City
Recoleta
State/Province
Santiago
Country
Chile
Facility Name
Hospital Barros Luco Trudeau
City
San Miguel
State/Province
Santiago
Country
Chile
Facility Name
CIPAM - Clínica Pedro Montt
City
Santiago
Country
Chile
Facility Name
Hospital Base Valdivia
City
Valdivia
Country
Chile
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51 000
Country
Croatia
Facility Name
Psychiatric Hospital Vrapce
City
Zagreb
ZIP/Postal Code
10 090
Country
Croatia
Facility Name
Croatian institute for brain research Neuron
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Beer Ya'acov Mental Health Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shalvata Mental Health Center, Ward B
City
Hod Hasharon
ZIP/Postal Code
45100
Country
Israel
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
ZIP/Postal Code
45100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Oranje Hospital
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Rand Clinic
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Private Practice
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Flexivest fourteen Research Centre
City
Cape Town
State/Province
W Cape
ZIP/Postal Code
7535
Country
South Africa
Facility Name
Cape Trial Centre
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Crompton Medical Centre East
City
Natal
ZIP/Postal Code
3600
Country
South Africa
Facility Name
Weskoppies Hospital
City
Pretoria West
ZIP/Postal Code
0001
Country
South Africa
Facility Name
King Chulalongkorn Memorial Hospital
City
Chulalongkorn University
State/Province
Bangkok
Country
Thailand
Facility Name
Somdet Chaopraya Institute of Psychiatry
City
Klongsan
State/Province
Bangkok
Country
Thailand
Facility Name
Suan Prung Psychiatric Hospital
City
Muang
State/Province
Chiang Mai
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
21075600
Citation
Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31.
Results Reference
background
PubMed Identifier
22395527
Citation
Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/YIC.0b013e32835281ef.
Results Reference
result
PubMed Identifier
33098548
Citation
Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24.
Results Reference
derived
PubMed Identifier
32370778
Citation
Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1.
Results Reference
derived
PubMed Identifier
28433500
Citation
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Results Reference
derived

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Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

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