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

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lurasidone
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

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

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

  • Synergy Escondido,710 East Grand Ave.
  • Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
  • Excell Research, Inc,3998 Vista Way,Suite 100
  • University of California at Irvine Medical Center
  • California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
  • California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
  • University of Colorado
  • Florida Clinical Research Center, LLC,3914 State Road 64 East
  • Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
  • Depression and Anxiety Disorders Research Institute
  • Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
  • American Medical Research Inc.,1200 Harger Road Suite 415
  • Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
  • Sheppard Pratt Health System,6501 North Charles Street
  • Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
  • Neurobehavioral Research, Inc.
  • Finger Lakes Clinical Research
  • Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
  • Mood Disorders Program-UHCMC
  • MetroHealth System
  • CRI Worldwide, LLC
  • FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200
  • Medical Services Prague s.r.o.
  • Psychiatricka ambulance
  • BIALBI s.r.o., Psychiatricke Oddeleni
  • Clintrial, s.r.o.
  • Hopital Caremeau, Service de Psychiatrie A
  • Zans Ritter, Marcel
  • S V Medical College
  • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
  • Samvedna Hospitals
  • Seth K M School of P G Medicine & Research
  • Mental Illness Treatment Rehabilitationi Foundation
  • Spandana Nursing Home
  • Sujata Birla Hospital & Research Centre
  • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
  • Manobal Med. Research Centre
  • Spitalul Clinic de Urgenta Militar Central
  • 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
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
  • Bekhterev Scientific Research Psychoneurological Institute
  • Psychoneurology Dispensary #4
  • Cape Trial Centre
  • Paarl Medical Centre
  • Clinika
  • Dey Clinic
  • Vereeniging Medi-Clinic
  • Chair of Psychiatry and Medical Psychology
  • Reg. Psychiatric Hospital
  • Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
  • CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
  • Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

lurasidone low arm

Placebo

lurasidone high arm

Arm Description

Outcomes

Primary Outcome Measures

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.

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)
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.

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
NCT00868699
Brief Title
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Official Title
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone 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
February 2012 (Actual)
Study Completion Date
February 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 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, Depression

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
lurasidone low arm
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
lurasidone high arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lurasidone
Intervention Description
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
Intervention Type
Drug
Intervention Name(s)
lurasidone
Intervention Description
lurasidone 20 mg/day for Days 1-7
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Description
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
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
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
Time Frame
Baseline to Week 6
Title
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Description
Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.
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: 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 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
Synergy Escondido,710 East Grand Ave.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
City
Garden Grove
State/Province
California
ZIP/Postal Code
92645
Country
United States
Facility Name
Excell Research, Inc,3998 Vista Way,Suite 100
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 Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Clinical Research Center, LLC,3914 State Road 64 East
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Depression and Anxiety Disorders Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
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
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
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
Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
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
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
Medical Services Prague s.r.o.
City
Kolejni 429-5
State/Province
Praha
Country
Czech Republic
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
Country
Czech Republic
Facility Name
Clintrial, s.r.o.
City
Praha
ZIP/Postal Code
10 100 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
S V 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
Seth K M School of P G Medicine & Research
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Mental Illness Treatment Rehabilitationi Foundation
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
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
Spitalul Clinic de Urgenta Militar Central
City
Bucdresti
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
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
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
Chair of Psychiatry and Medical Psychology
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Reg. Psychiatric Hospital
City
Odessa
Country
Ukraine
Facility Name
Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
Facility Name
CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
City
Vinnitsia
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
24170180
Citation
Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.
Results Reference
result
PubMed Identifier
30102967
Citation
Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.
Results Reference
derived
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
PubMed Identifier
26363720
Citation
Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.
Results Reference
derived
PubMed Identifier
25844756
Citation
McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.
Results Reference
derived

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

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