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Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

Primary Purpose

Bipolar Depression

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

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar I Depression, Lurasidone, Latuda

Eligibility Criteria

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

Inclusion Criteria:

  1. Provide written informed consent and is 18 to 75 years of age inclusive.
  2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
  3. Has a lifetime history of at least one bipolar manic or mixed manic episode.
  4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
  5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
  6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
  7. Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

  1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).
  3. Hospitalization for a manic or mixed episode within the past two months.
  4. Used investigational compound within past 6 months.
  5. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

Sites / Locations

  • Clinical Innovations, Inc.
  • Clinical Innovations Inc.
  • Artemis Institute for Clinical Research
  • Sharp Mesa Vista Hospital
  • Clinical Innovations inc.
  • Collaborative Neuroscience Network
  • Colorado Clinical Trials Inc.
  • Accurate Clinical Trials
  • Clinical Neuroscience Solutions Inc.
  • Northwest Behavioral Research Center
  • Institute for Behavioral Medicine LLC
  • Precise Research Centers
  • Village Clinical Research Inc.
  • Medical & Behavioral Health Research
  • Zarzar Psychiatric Associates, PLLC
  • Summit Research Network (Oregon) Inc.
  • Lehigh Valley Hospital
  • Clinical Neuroscience Solutions, Inc.
  • FutureSearch Clinical Trials, LP
  • Pillar Clinical Research
  • Red Oak Psychiatry Associates, PA
  • Summit Research Network (Seattle) LLC
  • Clinical Research Group Edmonton Inc
  • Okanagan Clinical Trials
  • Pierre-Janet Hospital
  • Hopital Louis-H Lafontaine
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  • Centro de Investigacion y Atencion para la Salud Mental
  • CISNE - UIC Campo Abierto
  • Hospital Mental de Antioquia
  • Psychiatricka ambulance
  • Vojenska nemocnice Olomouc
  • Clintrial, s.r.o.
  • Psychiatry Trial s.r.o.
  • Brain Mind Behavior Neuroscience Research Institute
  • Shanti Nursing Home
  • SBKS Medical College and Hospital, Brij Psychiatry Hospital
  • Abhaya Hospital Psychiatry
  • K.S. Hegde Medical Academy
  • Poona Hospital & Research Center
  • Mahatma Ghandi Institute of Medical Sciences
  • Mental Health Care & Research
  • R.K. Yadav Memorial Mental Health & De-addiction Hospital
  • Mahendru Psychiatric Center
  • Chatrapati Shau Maharaj Medical University
  • Ongata Hospital
  • Kohnodai Hospital, National Center for Global Health & Medicine
  • National Hospital Organization Hizen Psychiatric Center
  • National Center of Neurology & Psychiatry
  • Asakayama General Hospital
  • Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
  • Neuromeda JSC
  • Ziegzdriai Mental Hospital, Public Institution
  • Silutes Mental Health & Psychtherapy Center, JSC
  • Seskines Outpatient Clinic, Public Institution
  • Zirmunai Mental Health Center, Public Institution
  • Hospital Nacional Arzobispo Loayza
  • Hospital Nacional Hipolito Unanue
  • Clinica Vesalio
  • Centrum zdravia R. B. K. s.r.o.
  • Bojniciach
  • Psychiatricka ambulancia Mentum s.r.o.
  • FNsP Bratislava, Nemocnica Ruzinov
  • Nemocnica s poliklinikou Liptovsky Milulas
  • PsychoLine s.r.o.
  • Nemocnica s poliklikou Sv. Barbory
  • Pro mente sana
  • Kherson Regional Psychiatric Hospital
  • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
  • Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
  • St. In. Inst of Neurol, Psych, and Narcol of the AMSU
  • Kyiv City Psychoneurological Hospital #2
  • Lviv Regional Clinical Psychiatric Hospital
  • Ternopil Regional Municipal Dispensary, Narcology Dept.
  • Zapor. Reg. CI Hospital, Zaporizhzhia SMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lurasidone 20-120 mg flexible dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Secondary Outcome Measures

Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Full Information

First Posted
January 25, 2011
Last Updated
October 31, 2013
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01284517
Brief Title
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Acronym
PREVAIL3
Official Title
A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (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 HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 20-120 mg flexible dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Other Intervention Name(s)
Latuda
Intervention Description
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Equivalent to Lurasidone dosing
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Description
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Time Frame
Baseline to week 6
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Description
CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Time Frame
Baseline to week 6
Title
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Description
SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Time Frame
Baseline to week 6

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 is 18 to 75 years of age inclusive. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features. Has a lifetime history of at least one bipolar manic or mixed manic episode. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after Good physical health on the basis of medical history, physical examination, and laboratory screening. Exclusion Criteria: Subject is 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 Bipolar I Disorder). Hospitalization for a manic or mixed episode within the past two months. Used investigational compound within past 6 months. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 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
Clinical Innovations, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Clinical Innovations Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Colorado Clinical Trials Inc.
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80130
Country
United States
Facility Name
Accurate Clinical Trials
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Institute for Behavioral Medicine LLC
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Village Clinical Research Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Medical & Behavioral Health Research
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Zarzar Psychiatric Associates, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Summit Research Network (Oregon) Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Clinical Trials, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Red Oak Psychiatry Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Summit Research Network (Seattle) LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Clinical Research Group Edmonton Inc
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6W6
Country
Canada
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Pierre-Janet Hospital
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J9A 1K7
Country
Canada
Facility Name
Hopital Louis-H Lafontaine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
City
Barranquilla
Country
Colombia
Facility Name
Centro de Investigacion y Atencion para la Salud Mental
City
Bogota
ZIP/Postal Code
103
Country
Colombia
Facility Name
CISNE - UIC Campo Abierto
City
Bogota
Country
Colombia
Facility Name
Hospital Mental de Antioquia
City
Cali
Country
Colombia
Facility Name
Psychiatricka ambulance
City
Brno-mesto
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Vojenska nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
711 11
Country
Czech Republic
Facility Name
Clintrial, s.r.o.
City
Praha
ZIP/Postal Code
10 100 00
Country
Czech Republic
Facility Name
Psychiatry Trial s.r.o.
City
Praha
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Brain Mind Behavior Neuroscience Research Institute
City
Vishakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530002
Country
India
Facility Name
Shanti Nursing Home
City
Kanchanpalli
State/Province
Aurangabad, Maharashtra
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
Abhaya Hospital Psychiatry
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560027
Country
India
Facility Name
K.S. Hegde Medical Academy
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575018
Country
India
Facility Name
Poona Hospital & Research Center
City
Pune
State/Province
Mahara
ZIP/Postal Code
411 030
Country
India
Facility Name
Mahatma Ghandi Institute of Medical Sciences
City
Wardha
State/Province
Mahara
ZIP/Postal Code
442102
Country
India
Facility Name
Mental Health Care & Research
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
R.K. Yadav Memorial Mental Health & De-addiction Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302021
Country
India
Facility Name
Mahendru Psychiatric Center
City
Kanpur
State/Province
Uttar Prad
ZIP/Postal Code
208005
Country
India
Facility Name
Chatrapati Shau Maharaj Medical University
City
Lucknow
State/Province
Utter Prad
ZIP/Postal Code
226003
Country
India
Facility Name
Ongata Hospital
City
Hachioji-shi
ZIP/Postal Code
192 0153, 13
Country
Japan
Facility Name
Kohnodai Hospital, National Center for Global Health & Medicine
City
Ichikawa
ZIP/Postal Code
272 8516 12
Country
Japan
Facility Name
National Hospital Organization Hizen Psychiatric Center
City
Kanzaki-gun
ZIP/Postal Code
842 0192 41
Country
Japan
Facility Name
National Center of Neurology & Psychiatry
City
Kodaira-shi
ZIP/Postal Code
187 8551 13
Country
Japan
Facility Name
Asakayama General Hospital
City
Sakai-shi
ZIP/Postal Code
590 0018, 27
Country
Japan
Facility Name
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
City
Takatsuki
ZIP/Postal Code
569-1041
Country
Japan
Facility Name
Neuromeda JSC
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
Ziegzdriai Mental Hospital, Public Institution
City
Kaunas
ZIP/Postal Code
53136
Country
Lithuania
Facility Name
Silutes Mental Health & Psychtherapy Center, JSC
City
Silute
ZIP/Postal Code
99142
Country
Lithuania
Facility Name
Seskines Outpatient Clinic, Public Institution
City
Vilnius
ZIP/Postal Code
07156
Country
Lithuania
Facility Name
Zirmunai Mental Health Center, Public Institution
City
Vilnius
ZIP/Postal Code
09112
Country
Lithuania
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
ZIP/Postal Code
01
Country
Peru
Facility Name
Hospital Nacional Hipolito Unanue
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Clinica Vesalio
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Centrum zdravia R. B. K. s.r.o.
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Bojniciach
City
Bojnice
ZIP/Postal Code
97201
Country
Slovakia
Facility Name
Psychiatricka ambulancia Mentum s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
FNsP Bratislava, Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Liptovsky Milulas
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Facility Name
PsychoLine s.r.o.
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Facility Name
Nemocnica s poliklikou Sv. Barbory
City
Roznava
ZIP/Postal Code
048 01
Country
Slovakia
Facility Name
Pro mente sana
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Kherson Regional Psychiatric Hospital
City
Kherson
State/Province
Vil Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
St. In. Inst of Neurol, Psych, and Narcol of the AMSU
City
Kharkov
Country
Ukraine
Facility Name
Kyiv City Psychoneurological Hospital #2
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Lviv Regional Clinical Psychiatric Hospital
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Ternopil Regional Municipal Dispensary, Narcology Dept.
City
Ternopil
ZIP/Postal Code
46020
Country
Ukraine
Facility Name
Zapor. Reg. CI Hospital, Zaporizhzhia SMU
City
Zaporizhzhya
ZIP/Postal Code
69032
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27089521
Citation
Suppes T, Kroger H, Pikalov A, Loebel A. Lurasidone adjunctive with lithium or valproate for bipolar depression: A placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res. 2016 Jul;78:86-93. doi: 10.1016/j.jpsychires.2016.03.012. Epub 2016 Mar 31.
Results Reference
derived

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Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

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