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Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurasidone
Olanzapine
Placebo comparator
Lurasidone 40 mg tablets
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 Schizophrenia, Latuda, Lurasidone

Eligibility Criteria

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

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

Sites / Locations

  • K&S Professional Research Services LLC
  • Woodland International Research Group, LLC
  • Clinical Pharmacological Studies, Inc.
  • Excell Research
  • University of California at Irvine Medical Center
  • California Clinical Trials
  • CNRI - San Diego, LLC
  • UCSD Medical Center
  • Collaborative Neuroscience Network Inc.
  • Florida Clinical Research Center, LLC
  • Segal Institute for Clinical Research
  • Atlanta Center for Medical Research
  • Uptown Research Institute, LLC
  • Alexian Brothers Health System
  • Lousiana Clinical Research, LLC
  • Precise Research Center
  • St. Charles Psychiatric Associates-Midwest Research
  • St. Louis Clinical Trials
  • CRI Worldwide @ Lourdes
  • Neurobehavioral Research Inc.
  • University of North Carolina at Chapel Hill
  • Keystone Clinical Studies, LLC
  • Vanderbilt Heart and Vascular Institute
  • Community Clinical Research, Inc.
  • Claghorn-Lesem Research Clinic, Inc.
  • Instituto Colombiano del Sistema Nervioso Clinica Montserrat
  • CIPNA Centro de Investigaciones y Proyectos en Neurociencias
  • Centro de Investigacion y Atencion para la Salud Mental
  • Centro de Investigaciones del Sistema Nervioso Limitada
  • Psynapsis Salud Mental, S.A.
  • Vijayawada Institute of Mental Health and Neurosciences
  • Government Hospital for Mental Care
  • Hospital for Mental Health - Dept of Psychiatry
  • Sheth Vadilal Sarabhai General Hospital
  • SBKS Medical College and Brij Psychiatry Hospital
  • Victoria Hospital
  • Kasturba Medical College
  • Father Muller Institute of Medical Education and Research
  • Justice K.S. Hedge Charitable Hospital
  • Kasturba Hospital
  • JSS Medical College and Hospital - Dept of Psychiatry
  • Shanti Nursing Home
  • Deenanath Mangeshkar Hospital
  • Madras Medical College & Government General Hospital
  • Ziegzdriai Mental Hospital, Public Institution
  • Klaipeda Mental Hospital, Public Institution
  • Siauliai Mental Hospital, Public Institution
  • Republican Vilnius Psychiatry Hospital, Public Institution
  • Davao Medical School Foundation Hospital
  • Makati Medical Center
  • National Center for Mental Health
  • Metro Psych Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lurasdione 40mg tablets

120mg

15mg Olz

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.

Secondary Outcome Measures

CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.

Full Information

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

Unique Protocol Identification Number
NCT00615433
Brief Title
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Official Title
A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 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 developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
478 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasdione 40mg tablets
Arm Type
Experimental
Arm Title
120mg
Arm Type
Experimental
Arm Title
15mg Olz
Arm Type
Active Comparator
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
120mg/day
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
15mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Placebor Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone 40 mg tablets
Intervention Description
Lurasidone 40 mg tablets
Primary Outcome Measure Information:
Title
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
Description
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
Description
The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
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
Clinical Pharmacological Studies, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
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
California Clinical Trials
City
Paramount
State/Province
California
ZIP/Postal Code
90723
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 Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Fruitland Park
State/Province
Florida
ZIP/Postal Code
24731
Country
United States
Facility Name
Segal Institute for Clinical Research
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
Uptown Research Institute, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alexian Brothers Health System
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Lousiana Clinical Research, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
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
CRI Worldwide @ Lourdes
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Neurobehavioral Research Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
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
19401
Country
United States
Facility Name
Vanderbilt Heart and Vascular Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Instituto Colombiano del Sistema Nervioso Clinica Montserrat
City
Cundinamarca
State/Province
Bogota
Country
Colombia
Facility Name
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
City
Barranquilla
Country
Colombia
Facility Name
Centro de Investigacion y Atencion para la Salud Mental
City
Bogota
Country
Colombia
Facility Name
Centro de Investigaciones del Sistema Nervioso Limitada
City
Bogota
Country
Colombia
Facility Name
Psynapsis Salud Mental, S.A.
City
Risaralda
Country
Colombia
Facility Name
Vijayawada Institute of Mental Health and Neurosciences
City
Vijaywada
State/Province
Andh Prad
ZIP/Postal Code
520002
Country
India
Facility Name
Government Hospital for Mental Care
City
Visakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530017
Country
India
Facility Name
Hospital for Mental Health - Dept of Psychiatry
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380004
Country
India
Facility Name
Sheth Vadilal Sarabhai General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
SBKS Medical College and Brij Psychiatry Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Victoria Hospital
City
Bangalore
State/Province
Karna
ZIP/Postal Code
56002
Country
India
Facility Name
Kasturba Medical College
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Father Muller Institute of Medical Education and Research
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575002
Country
India
Facility Name
Justice K.S. Hedge Charitable Hospital
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575018
Country
India
Facility Name
Kasturba Hospital
City
Manipal
State/Province
Karna
ZIP/Postal Code
576104
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
Shanti Nursing Home
City
Aurangabad
State/Province
Mahara
ZIP/Postal Code
431005
Country
India
Facility Name
Deenanath Mangeshkar Hospital
City
Pune
State/Province
Mahara
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
Ziegzdriai Mental Hospital, Public Institution
City
Kaunas
ZIP/Postal Code
53136
Country
Lithuania
Facility Name
Klaipeda Mental Hospital, Public Institution
City
Klaipeda
ZIP/Postal Code
91251
Country
Lithuania
Facility Name
Siauliai Mental Hospital, Public Institution
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Republican Vilnius Psychiatry Hospital, Public Institution
City
Vilnius
ZIP/Postal Code
11205
Country
Lithuania
Facility Name
Davao Medical School Foundation Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1227
Country
Philippines
Facility Name
National Center for Mental Health
City
Mandaluyong City
ZIP/Postal Code
1553
Country
Philippines
Facility Name
Metro Psych Facility
City
Mandaue City
ZIP/Postal Code
6014
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
21676992
Citation
Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.
Results Reference
background
PubMed Identifier
23541189
Citation
Stahl SM, Cucchiaro J, Simonelli D, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J Clin Psychiatry. 2013 May;74(5):507-15. doi: 10.4088/JCP.12m08084. Epub 2013 Mar 13.
Results Reference
result
PubMed Identifier
34751928
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.
Results Reference
derived
PubMed Identifier
24955752
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.
Results Reference
derived

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Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

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