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Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lurasidone
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, Depression, Lurasidone, Latuda

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
  • Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.

Exclusion Criteria:

  • Imminent risk of suicide, injury to self or to others, or damage to property
  • Subject has evidence of severe movement disorders.
  • Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).

Sites / Locations

  • Woodland International Research Inc
  • South Coast Clinical Trials Inc.
  • Catalina Research Institute
  • Clinical Innovations Inc.
  • Synergy Escondido
  • Collaborative Neuroscience Network Inc
  • Cedars-Sinai Medical Center
  • Florida Clinical Research Center LLC
  • Excell Research, Inc
  • University of California at Irvine Medical Center
  • CNRI - Los Angeles LLC
  • Clinical Innovations Inc.
  • California Neuropsychopharmacology Clinical Research Instit
  • Artemis Institute for Clinical Research LLC
  • Sharp Mesa Vista Hospital
  • Clinical Innovations Inc.
  • Stanford University School of Medicine
  • Collaborative Neuroscience Network Inc.
  • University of Colorado
  • MCB Clinical Research Centers-Colorado Springs
  • Florida Clinical Research Center LLC
  • Florida Clinical Research Center LLC
  • Accurate Clinical Trials
  • Clinical Neuroscience Solutions INc.
  • University of South Florida Institute - Tampa
  • Janus Center for Psychiatric Research
  • Northwest Behavioral Research Center
  • Institute for Behavioral Medicine LLC
  • American Medical Research
  • Lake Charles Clinical Trials LLC
  • Booker, J. Gary, MD. APMC
  • Sheppard Pratt Health System
  • Capitol Clinical Research
  • Precise Research Centers
  • Midwest Research Group
  • CRI Worldwide, LLC
  • Albuquerque Neuroscience Inc.
  • Social Psychiatry Research Institute
  • Neurobehavioral Research, Inc
  • Village Clinical Research Inc.
  • Medical & Behavioral Health Research PC
  • Finger Lakes Clinical Research
  • Zarzar Psychiatric Associates PLLC
  • Richard H. Weisler & Associates
  • Quest Therapeutics
  • Psychiatric Professional Services Inc
  • Mood Disorders Program-UHCMC
  • MetroHealth System
  • Midwest Clinical Research Center
  • Summit Research Network (Oregon) Inc.
  • Lehigh Valley Hospital
  • Clinical Neuroscience Solutions Inc.
  • FutureSearch Clinical Trials LP
  • FutureSearch Trials
  • Pillar Clinical Research LLC
  • Red Oak Psychiatry Associates, PA
  • Wharton Research Center
  • Summit Research Network (Seattle) LLC
  • Clinical Research Group Edmonton
  • Okanagan Clinical Trials
  • Pierre-Janet Hospital
  • Hopital Louis-H Lafontaine
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
  • E.S.E. Hospital Mental de Antioquia
  • Centro de Investigacion y Atencion para la Salud Mental
  • Centro de Investigaciones del Sistema Nerviosa Limitada-Gr
  • Saint Anne, s.r.o., Psychiatricke oddeleni
  • BIALBI s.r.o. Psychiatricke oddeleni
  • Psychiatricka ambulance Prosek
  • Vojenska nemocnice Olomouc
  • Clintrial, s.r.o.
  • Psychiatry Trial s.r.o.
  • Medical Services Prague s.r.o.
  • Hopital Caremeau, Service de Psychiatrie A
  • Zans Ritter, Marcel
  • S V Medical College
  • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
  • Brain Mind Behaviour Neurosciences Research Institute
  • Seth K M School of P G Medicine & Research
  • Mental Illness Treatment Rehabilitation Foundation (MITR)
  • Brij Psychiatry Hospital & Muskaan Research Centre
  • Spandana Nursing Home
  • Abhava Hospital
  • K.S. Hegde Medical Academy
  • Shanti Nursing Home
  • Poona Hospital & Research Center
  • Mahatma Gandhi Institute of Medical Sciences
  • Dr. Tambi's Neuropsychiatry Center
  • R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
  • Mahendru Psychiatric Centre
  • Manobal Med. Research Centre
  • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
  • Shree Hatkesh Health Foundation
  • Samvedna Hospitals
  • Chhatrapati Shahuji Maharaj
  • Sujata Dirla Hospital & Research Centre
  • Ongata Hospital
  • Kohnodai Hp., National Center for Global Health and Medicine
  • NHO Hizen Psychiatric Center
  • National Center of Neurology and Psychiatry
  • Asakayama General Hospital
  • Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
  • Neuromeda, JSC
  • Kaunas Hospital Division Marui Hospital, Public Institution
  • Silutes Mental Health and Psychotherapy Center, JSC
  • Seskines Outpatient Clinic, Public Institution
  • Zirmunai Mental Health Center, Public Institution
  • Hospital Nacional Hipolito Unanue
  • Hospital Nacional Arzobispo Loayza
  • Clinica Vesalio
  • ZOZ Poradnia Zdrowia Psychicznego
  • Praktyka Lekarska Sensorium S.M.O.
  • 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
  • Centrul de Recuperare si Reabilitare Gura Ocnitei
  • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • Russian State Medical University of RosZdrav
  • Moscow Medical Academy name I.M. Sechenov
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
  • Bekhterev Scientific Research Psychoneurological Institute
  • Psychoneurology Dispensary #4
  • LLC International Medical Centre "SOGAZ"
  • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
  • Psychiatricka ambulancia Mentum, s.r.o.
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
  • Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
  • PsychoLine s.r.o. Psychiatricka ambulancia
  • Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
  • Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
  • Pro mente sana s.r.o. Psychiaricka ambulancia
  • Cape Trial Centre
  • Groote Schuur Hospital
  • Paarl Medical Centre
  • Clinika, Murray and Roberts Building
  • Dey Clinic
  • Vereeniging Medi-Clinic
  • Regional Clinical Hospital n.a.l.l.
  • Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
  • Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
  • St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
  • Kherson Regional Psychiatric Hospital
  • Kyiv City Psychoneurological Hospital #2
  • Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
  • Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
  • Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
  • Crimean republican Clinical Psychiatric Hospital
  • Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
  • Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
  • Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lurasidone

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)

Secondary Outcome Measures

Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.

Full Information

First Posted
March 23, 2009
Last Updated
March 15, 2016
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00868959
Brief Title
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Official Title
A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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, Depression, Lurasidone, Latuda

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
817 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lurasidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lurasidone
Intervention Description
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
Description
Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Time Frame
24 weeks
Title
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Description
This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.
Time Frame
24 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: Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699. Exclusion Criteria: Imminent risk of suicide, injury to self or to others, or damage to property Subject has evidence of severe movement disorders. Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).
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
Clinical Innovations Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
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
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
Florida Clinical Research Center LLC
City
Maitland
State/Province
California
ZIP/Postal Code
32751
Country
United States
Facility Name
Excell Research, Inc
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
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
92506
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Instit
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Artemis Institute for Clinical Research LLC
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
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MCB Clinical Research Centers-Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80917
Country
United States
Facility Name
Florida Clinical Research Center LLC
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
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
University of South Florida Institute - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Rosewekk
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
American Medical Research
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Lake Charles Clinical Trials LLC
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
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Capitol Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Midwest Research Group
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
CRI Worldwide, LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Albuquerque Neuroscience Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Research, Inc
City
Cedarhurst
State/Province
New York
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 PC
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Zarzar Psychiatric Associates PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Richard H. Weisler & Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Quest Therapeutics
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Psychiatric Professional Services Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
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
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
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
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
FutureSearch Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinical Research LLC
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
Wharton Research Center
City
Wharton
State/Province
Texas
ZIP/Postal Code
77488
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
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 2H4
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 Investigations
City
Barranquilla
Country
Colombia
Facility Name
E.S.E. Hospital Mental de Antioquia
City
Bello
Country
Colombia
Facility Name
Centro de Investigacion y Atencion para la Salud Mental
City
Bogota
Country
Colombia
Facility Name
Centro de Investigaciones del Sistema Nerviosa Limitada-Gr
City
Bogota
Country
Colombia
Facility Name
Saint Anne, s.r.o., Psychiatricke oddeleni
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
Psychiatricka ambulance Prosek
City
Lovosicka
Country
Czech Republic
Facility Name
Vojenska nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
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
Medical Services Prague s.r.o.
City
Praha
ZIP/Postal Code
6 160 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
Brain Mind Behaviour Neurosciences Research Institute
City
Vishakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530002
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 Rehabilitation Foundation (MITR)
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Brij Psychiatry Hospital & Muskaan Research Centre
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Spandana Nursing Home
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560010
Country
India
Facility Name
Abhava Hospital
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
Shanti Nursing Home
City
Aurangabad
State/Province
Mahara
ZIP/Postal Code
431001
Country
India
Facility Name
Poona Hospital & Research Center
City
Pune
State/Province
Mahara
ZIP/Postal Code
411 030
Country
India
Facility Name
Mahatma Gandhi Institute of Medical Sciences
City
Wardha
State/Province
Mahara
ZIP/Postal Code
442001
Country
India
Facility Name
Dr. Tambi's Neuropsychiatry Center
City
Jaipur
State/Province
Rajaasthan
ZIP/Postal Code
302017
Country
India
Facility Name
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302021
Country
India
Facility Name
Mahendru Psychiatric Centre
City
Kanpur
State/Province
Uttar Prad
ZIP/Postal Code
208005
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
Shree Hatkesh Health Foundation
City
Gujarat
ZIP/Postal Code
362002
Country
India
Facility Name
Samvedna Hospitals
City
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Chhatrapati Shahuji Maharaj
City
Lucknow
ZIP/Postal Code
22603
Country
India
Facility Name
Sujata Dirla Hospital & Research Centre
City
Mahara
ZIP/Postal Code
422101
Country
India
Facility Name
Ongata Hospital
City
Hachioji-shi
ZIP/Postal Code
192-0153
Country
Japan
Facility Name
Kohnodai Hp., National Center for Global Health and Medicine
City
Ichikawa-sha
ZIP/Postal Code
272-8516
Country
Japan
Facility Name
NHO Hizen Psychiatric Center
City
Kanzaki-gun
ZIP/Postal Code
842-0192
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira-shi
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Asakayama General Hospital
City
Sakai-shi
ZIP/Postal Code
590-0018
Country
Japan
Facility Name
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
City
Takatsuki-shi
ZIP/Postal Code
569-1041
Country
Japan
Facility Name
Neuromeda, JSC
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
Kaunas Hospital Division Marui Hospital, Public Institution
City
Kaunas
ZIP/Postal Code
53136
Country
Lithuania
Facility Name
Silutes Mental Health and Psychotherapy 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 Hipolito Unanue
City
Lima
ZIP/Postal Code
10
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Clinica Vesalio
City
Lima
ZIP/Postal Code
41
Country
Peru
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
Spitalul Clinic de Urgenta Militar Central
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
Centrul de Recuperare si Reabilitare Gura Ocnitei
City
Gura Ocnitei
ZIP/Postal Code
130083
Country
Romania
Facility Name
Spitalul Clinic de Neurologie si Psihiatrie Oradea
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Facility Name
Russian State Medical University of RosZdrav
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow Medical Academy name I.M. Sechenov
City
Moscow
ZIP/Postal Code
11935
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
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
City
Bojnice
ZIP/Postal Code
92701
Country
Slovakia
Facility Name
Psychiatricka ambulancia Mentum, s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Facility Name
PsychoLine s.r.o. Psychiatricka ambulancia
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Facility Name
Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
City
Roznava
ZIP/Postal Code
048 01
Country
Slovakia
Facility Name
Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Pro mente sana s.r.o. Psychiaricka ambulancia
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Cape Trial Centre
City
Cape Town, W. Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Paarl Medical Centre
City
Paarl, W. Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Clinika, Murray and Roberts Building
City
Port Elizabeth
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
Regional Clinical Hospital n.a.l.l.
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Kyiv City Psychoneurological Hospital #2
City
Kviv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
City
Odessa
ZIP/Postal Code
65006
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
Crimean republican Clinical Psychiatric Hospital
City
Simferopol
Country
Ukraine
Facility Name
Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
City
Ternopil
ZIP/Postal Code
46020
Country
Ukraine
Facility Name
Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
City
Vinnitsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.
City
Zaporizhzhia
ZIP/Postal Code
69032
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
29146409
Citation
Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.
Results Reference
derived

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Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

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