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Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lurasidone + (lithium or divalproex)
Placebo + (lithium or divalproex)
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, Latuda, Lurasidone

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is diagnosed with bipolar I disorder, most resent episode depressed
  • Subject must have a lifetime history of at least one bipolar manic or mixed episode
  • Subject must be taking lithium or divalproex at least 28 days prior to screening

Exclusion Criteria:

  • History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
  • Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
  • Imminent risk of suicide or injury to self, others, or property

Sites / Locations

  • Woodland International Research Inc.
  • South Coast Clinical Trials, Inc.
  • Catalina Research Institute
  • Synergy Escondido
  • Collaborative Neuroscience Network Inc.,12772 Valley View Street
  • Cedars-Sinai Medical Center
  • University of California at Irvine Medical Center
  • CNRI - Los Angeles LLC,8309 Telegraph Road
  • CNRI - San Diego, LLC
  • Stanford University School of Medicine
  • University of Colorado
  • Depression and Anxiety Disorders Research Institue
  • American Medical Research Inc.,1200 Harger Road Suite 415
  • American Medical Research, Inc., 1200 Harger Road Suite 415
  • J. Gary Booker, MD
  • Sheppard Pratt Health System,6501 North Charles Street
  • Capital Clinical Research,5515 Security Lane, Suite 525
  • Midwest Research Group
  • Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
  • Lake Charles Clinical Trials LLC,700 Spring Forest Road
  • Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
  • University of Cincinnati
  • Mood Disorders Program-UHCMC
  • MetroHealth System
  • Midwest Clinical research Center, One Elizabeth Place, Suite G-3
  • CRI Worldwide, LLC
  • FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200
  • Psychiatricka ambulance
  • BIALBI s.r.o. Psychiatricke oddeleni
  • Clintrial, s.r.o.
  • Medical Services Prague s.r.o.
  • Psychiatricka ambulance Prosek
  • Hopital Caremeau, Service de Psychiatrie A
  • Zans Ritter, Marcel
  • Jana Thomsen
  • SV Medical College
  • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
  • Samvedna Hospitals
  • Sheth Vadilal Sarabhai General Hospital
  • Mental Illness Treatment Rehabilitation Foundation (MITR)
  • Shree Hatkesh Health Foundation
  • Spandana Nursing Home
  • Sujata Birla Hospital & Research Centre
  • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
  • Manobal Med. Research Centre
  • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
  • ZOZ Poradnia Zdrowia Psychicznego
  • Praktyka Lekarska Sensorium S.M.O.
  • Wojewodzki Szpital Brodnowski SP ZOZ
  • Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
  • Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
  • Spitalul Clinic Judetean de Urgenta Cluj
  • Spitalul Clinic de Neuropsihiatrie Craiova
  • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
  • Russian State Medical University
  • Moscow Medical Academy named I.M. Sechenov
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
  • Bekhterev Scientific Research Psychoneurological Institute
  • Psychoneurology Dispensary #4
  • LLC International Medical Centre "SOGAZ"
  • Cape Trial Centre
  • Paarl Medical Centre
  • Clinika
  • Dey Clinic
  • Vereeniging Medi-Clinic
  • Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
  • Odesa Regional Psychoneurological Dispensary
  • Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
  • CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
  • Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lurasidone

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
STS 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
March 23, 2009
Last Updated
March 31, 2014
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00868452
Brief Title
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 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
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of 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, Latuda, Lurasidone

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lurasidone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lurasidone + (lithium or divalproex)
Intervention Description
lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
Intervention Type
Drug
Intervention Name(s)
Placebo + (lithium or divalproex)
Intervention Description
20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
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, 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 Week 6
Title
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Description
STS 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
Baselin 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: Subject is diagnosed with bipolar I disorder, most resent episode depressed Subject must have a lifetime history of at least one bipolar manic or mixed episode Subject must be taking lithium or divalproex at least 28 days prior to screening Exclusion Criteria: History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization 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
Woodland International Research Inc.
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
Catalina Research Institute
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Synergy Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.,12772 Valley View Street
City
Garden Grove
State/Province
California
ZIP/Postal Code
92645
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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
CNRI - Los Angeles LLC,8309 Telegraph Road
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
CNRI - San Diego, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Depression and Anxiety Disorders Research Institue
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
American Medical Research Inc.,1200 Harger Road Suite 415
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
American Medical Research, Inc., 1200 Harger Road Suite 415
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
J. Gary Booker, MD
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Sheppard Pratt Health System,6501 North Charles Street
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Capital Clinical Research,5515 Security Lane, Suite 525
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Midwest Research Group
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Lake Charles Clinical Trials LLC,700 Spring Forest Road
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Mood Disorders Program-UHCMC
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Midwest Clinical research Center, One Elizabeth Place, Suite G-3
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Psychiatricka ambulance
City
Brno - mesto
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
BIALBI s.r.o. Psychiatricke oddeleni
City
Litomerice
ZIP/Postal Code
412 01
Country
Czech Republic
Facility Name
Clintrial, s.r.o.
City
Praha
ZIP/Postal Code
10 100 00
Country
Czech Republic
Facility Name
Medical Services Prague s.r.o.
City
Praha
ZIP/Postal Code
6 160 00
Country
Czech Republic
Facility Name
Psychiatricka ambulance Prosek
City
Praha
ZIP/Postal Code
9 190 00
Country
Czech Republic
Facility Name
Hopital Caremeau, Service de Psychiatrie A
City
Nimes Cedex
ZIP/Postal Code
30 30029
Country
France
Facility Name
Zans Ritter, Marcel
City
Orvault
ZIP/Postal Code
44700
Country
France
Facility Name
Jana Thomsen
City
Berlin BE
ZIP/Postal Code
10245
Country
Germany
Facility Name
SV Medical College
City
Tirupati
State/Province
Andh Prad
ZIP/Postal Code
517507
Country
India
Facility Name
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
City
Vijaywada
State/Province
Andh Prad
ZIP/Postal Code
520002
Country
India
Facility Name
Samvedna Hospitals
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Sheth Vadilal Sarabhai General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Mental Illness Treatment Rehabilitation Foundation (MITR)
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Shree Hatkesh Health Foundation
City
Junagadh
State/Province
Gujarat
ZIP/Postal Code
362001
Country
India
Facility Name
Spandana Nursing Home
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560010
Country
India
Facility Name
Sujata Birla Hospital & Research Centre
City
Nashik
State/Province
Mahara
ZIP/Postal Code
422101
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
Manobal Med. Research Centre
City
Lucknow
State/Province
Uttar Prad
ZIP/Postal Code
226006
Country
India
Facility Name
Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
City
Delhi
ZIP/Postal Code
110092
Country
India
Facility Name
ZOZ Poradnia Zdrowia Psychicznego
City
Chelmno
ZIP/Postal Code
86-200
Country
Poland
Facility Name
Praktyka Lekarska Sensorium S.M.O.
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Wojewodzki Szpital Brodnowski SP ZOZ
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Spitalul Clinic de Neuropsihiatrie Craiova
City
Craiova
ZIP/Postal Code
200620
Country
Romania
Facility Name
Spitalul Clinic de Neurologie si Psihiatrie Oradea
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
City
Pitesti
ZIP/Postal Code
110069
Country
Romania
Facility Name
Russian State Medical University
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow Medical Academy named I.M. Sechenov
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Bekhterev Scientific Research Psychoneurological Institute
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
Facility Name
Psychoneurology Dispensary #4
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
LLC International Medical Centre "SOGAZ"
City
St. Petersburg
ZIP/Postal Code
198035
Country
Russian Federation
Facility Name
Cape Trial Centre
City
Cape Town, W. Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Paarl Medical Centre
City
Paarl, W. Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Clinika
City
Port Elizabeth, E. Cape
ZIP/Postal Code
6000
Country
South Africa
Facility Name
Dey Clinic
City
Pretoria, Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Vereeniging Medi-Clinic
City
Vereeniging, Free State
ZIP/Postal Code
1941
Country
South Africa
Facility Name
Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Odesa Regional Psychoneurological Dispensary
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
Facility Name
CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog
City
Vinnitsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
24170221
Citation
Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.
Results Reference
result
PubMed Identifier
27529375
Citation
Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.
Results Reference
derived
PubMed Identifier
27215976
Citation
Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.
Results Reference
derived
PubMed Identifier
26730454
Citation
Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.
Results Reference
derived

Learn more about this trial

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

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