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Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurasidone
Lurasidone
Quetiapine XR
Placebo
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, SM-13496, 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
  • Clinical Pharmacological Studies, Inc.
  • Comprehensive Neuroscience, Inc
  • Clinical Innovations, Inc.
  • Synergy Escondido
  • Collaborative Neuroscience Network
  • Apostle Clinical Trials, Inc.
  • California Clinical Trials
  • Pasadena Research Institute
  • CNRI-Los Angeles. LLC
  • Clinical Innovations, Inc.
  • CNRI-San Diego
  • UCSD Medical Center
  • Segal Institute for Clinical Research
  • Comprehensive Neuroscience, Inc.
  • Florida Clinical Research Center
  • Florida Clinical Research Center, LLC
  • Lake Charles Clinical Trials
  • Booker, J. Gary, MD. APMC
  • Precise Clinical Research
  • St. Charles Psychiatric Associates
  • St. Louis Research, Inc.
  • CRI Worldwide
  • Comprehensive Neuroscience, Inc
  • Segal Institute for Clinical Research
  • Community Clinical Research
  • Future Search Trials of Neurology
  • Pillar Clinical Research
  • Vijayawada Institute of Mental Health and Neurosciences
  • S.V. Medical College
  • Seth K M School of P G Medicine & Research
  • SBKS Medical Institute and Research Centre
  • Justice K.S. Hegde Charitable Hospital
  • JSS Medical College and Hospital
  • Shanti Nursing Home
  • Deenanath Mangeshkar Hospital and Research Centre
  • Mahatma Gandhi Institute of Medical Sciences
  • Madras Medical College & Government General Hospital
  • Spitalul Clinic Judetean de Urgenta Arad
  • Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
  • Spitalul Judetean Arges
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
  • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • SEI of H.P. Educat. Northern SMU
  • St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko
  • Moscow Scientific Research Institute of Psychiatry
  • Institution of RAMS Mental Health Research Center of RAMS
  • City Clinical Psichiatric Hospital #1
  • SHI Samara Psychiatric Hospital
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
  • City Psychiatric Hospital #3 of Skvortsov-Stepanov
  • City Psychiatric Hospital #4
  • SHI City Psychoneurological Dispensary #7
  • St. Petersburg GUZ City Psychiatric Hospital #6
  • Kherson Regional Psychiatric Hospital
  • RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology
  • Chair of Psychiatry and Medical Psychology
  • Centre of Novel Treatment and Rehabilitation of Psychotic disorders
  • Kyiv City Psychoneurological Hospital
  • Lviv Reg.St.Cl.Psych.Hosp
  • Reg. Psychiatric Hospital
  • Poltava Regional Clinical Psychiatric Hospital,
  • Crimean republican Clinical Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lurasidone 80mg

Lurasidone 160mg

Quetiapine XR

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

Secondary Outcome Measures

Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).

Full Information

First Posted
November 10, 2008
Last Updated
March 11, 2016
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00790192
Brief Title
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Acronym
PEARL 3
Official Title
A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 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 effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 80mg
Arm Type
Experimental
Arm Title
Lurasidone 160mg
Arm Type
Experimental
Arm Title
Quetiapine XR
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
Lurasidone 80 mg tablets
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
Lurasidone 4 40 mg tablets
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Intervention Description
Quetiapine XR 600mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo to Lurasidone or Quetiapine
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
Description
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Description
Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
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
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
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
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuroscience Network
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
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
92126
Country
United States
Facility Name
UCSD Medical Center
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
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Fruitland Park
State/Province
Florida
ZIP/Postal Code
34731
Country
United States
Facility Name
Lake Charles Clinical Trials
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
Precise Clinical Research
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
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
Comprehensive Neuroscience, Inc
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
Segal Institute for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78729
Country
United States
Facility Name
Future Search Trials of Neurology
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
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
Seth K M School of P G Medicine & Research
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
SBKS Medical Institute and Research Centre
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
Justice K.S. Hegde Charitable Hospital
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
574160
Country
India
Facility Name
JSS Medical College and Hospital
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Shanti Nursing Home
City
Aurangabad
State/Province
Maharastra
ZIP/Postal Code
431005
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharastra
ZIP/Postal Code
411004
Country
India
Facility Name
Mahatma Gandhi Institute of Medical Sciences
City
Sewagram
State/Province
Maharastra
ZIP/Postal Code
442102
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 de Psihiatrie Titan "Dr. Constantin Gorgos"
City
Bdul Nicolae Grigorescu nr. 41
State/Province
Bucuresti
ZIP/Postal Code
030440
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 Judetean Arges
City
Str. Negru Voda nr. 53
State/Province
Pitesti
ZIP/Postal Code
110069
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
SEI of H.P. Educat. Northern SMU
City
Arkhangelsk
ZIP/Postal Code
163060
Country
Russian Federation
Facility Name
St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko
City
Gatchina
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
Moscow Scientific Research Institute of Psychiatry
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Institution of RAMS Mental Health Research Center of RAMS
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
City Clinical Psichiatric Hospital #1
City
Nizhniy Novgorod
ZIP/Postal Code
603 155
Country
Russian Federation
Facility Name
SHI Samara Psychiatric Hospital
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
City
St. Petersburg
Country
Russian Federation
Facility Name
City Psychiatric Hospital #3 of Skvortsov-Stepanov
City
St. Petersburg
Country
Russian Federation
Facility Name
City Psychiatric Hospital #4
City
St. Petersburg
Country
Russian Federation
Facility Name
SHI City Psychoneurological Dispensary #7
City
St. Petersburg
Country
Russian Federation
Facility Name
St. Petersburg GUZ City Psychiatric Hospital #6
City
St. Petersburg
Country
Russian Federation
Facility Name
Kherson Regional Psychiatric Hospital
City
Kherson,vil.
State/Province
Stepanovka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Chair of Psychiatry and Medical Psychology
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Centre of Novel Treatment and Rehabilitation of Psychotic disorders
City
Kyiv
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
Poltava Regional Clinical Psychiatric Hospital,
City
Poltava
Country
Ukraine
Facility Name
Crimean republican Clinical Psychiatric Hospital
City
Simferopol
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
23415311
Citation
Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.
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
24330860
Citation
Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. doi: 10.1017/S1092852913000904. Epub 2013 Dec 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
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
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 6-week Phase 3 Study of Patients With Acute Schizophrenia.

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