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A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Primary Purpose

Schizophrenia

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 Schizophrenia focused on measuring Lurasidone, Latuda, Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has agreed to participate by providing written informed consent.
  • Subject will be eligible to participate if one of the following criteria is met:
  • Subject has completed the 28-week double-blind phase of study D1050238
  • Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
  • Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
  • Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
  • Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

  • Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
  • Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.

Sites / Locations

  • K and S Professional Research Services
  • Woodland International Research Inc.
  • Comprehensive Clinical Development Inc.
  • Diligent Clinical Trials
  • Synergy Clinical Research Center
  • CNS Network
  • AXIS Clinical Trials
  • Synergy Clinical Research Center
  • Excell Research, Inc.
  • CNRI-Los Angeles. LLC
  • California Neuropsychopharmacolgoy Clinical Research Insitute
  • Neuropsychiatric Research Center of Orange County
  • Collaborative Neuroscience Network
  • Florida Clinical Research Center, LLC
  • Accurate Clinical Trials
  • Galiz Research
  • Medical Research Group of Central Florida
  • Atlanta Center for Medical Research
  • Comprehensive NeuroScience Inc.
  • Lake Charles Clinical Trials, LLC
  • Lousiana Clinical Research, LLC
  • Center for Behavioral Health, LLC
  • Psychiatric Care and Research Center
  • Psych Care Consultants Research
  • Robert Lynn Horne, MD
  • CRI Worldwide LLC
  • Erie County Medical Center, Corp
  • Neurobehavioral Research Inc.
  • Comprehensive Clinical Development, Inc
  • Finger Lakes Clinical Research
  • Oklahoma Clinical Research
  • CRI Worldwide LLC at Kirkbride
  • Lincoln Research
  • Community Clinical Research, Inc.
  • FutureSearch Clinical Trials LP
  • FutureSearch Clinical Trials, LP
  • Pillar Clinical Research, LLC
  • Department of Psychiatry, University of Utah Health Sciences Center
  • Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)
  • Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
  • Dipartimento Salute Mentale ASL 1
  • A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4
  • Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
  • Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'
  • St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
  • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")
  • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
  • St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
  • Military Medical Academy, Clnic for Psychiatry
  • Institute of Mental Health
  • Clinical Centre Kragujevac, Clinic for psychiatry
  • Clinical Centre Nis, Clinic for mental health protection
  • Specialized hospital for psychiatric diseases "Sveti Vracevi"
  • Clinical Centre Vojvodine, Clinic for Psychiatry
  • Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie
  • Psychiatricka ambulancia Mentum s.r.o.
  • Psychiatricka nemocnica Michalovce n.o.
  • PsychoLine s.r.o. Psychiatricka ambulancia
  • Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
  • "Centrum zdravia R.B.K., spol. s.r.o.
  • Cape Trial Centre
  • Research Unit, Department of Psychiatry Free State Psychiatric Complex
  • Denmar Hospital Consulting Rooms

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lurasidone

Arm Description

Lurasidone 40 - 80mg flexible dose

Outcomes

Primary Outcome Measures

Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.

Secondary Outcome Measures

Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Short Form-12 Health Survey (SF-12)
The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Modified Specific Levels of Functioning (SLOF) Total Score.
The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.
Brief Adherence Rating Scale (BARS)
The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.
Smoking Questionnaire
Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
Intent to Attend Assessment
The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"

Full Information

First Posted
March 27, 2012
Last Updated
April 2, 2019
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01566162
Brief Title
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
Official Title
A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.
Detailed Description
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lurasidone
Arm Type
Experimental
Arm Description
Lurasidone 40 - 80mg flexible dose
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
Lurasidone 40-80 mg taken orally taken once daily
Primary Outcome Measure Information:
Title
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
Description
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
Time Frame
12 weeks
Title
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Time Frame
Baseline to week 12 LOCF endpoint
Title
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
Description
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Time Frame
Baseline to week 12 LOCF endpoint
Secondary Outcome Measure Information:
Title
Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
Description
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Time Frame
Baseline to week 12 LOCF endpoint
Title
Short Form-12 Health Survey (SF-12)
Description
The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame
Baseline to week 12 LOCF endpoint
Title
Modified Specific Levels of Functioning (SLOF) Total Score.
Description
The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.
Time Frame
12 weeks
Title
Brief Adherence Rating Scale (BARS)
Description
The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.
Time Frame
12 weeks
Title
Smoking Questionnaire
Description
Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
Time Frame
12 weeks
Title
Intent to Attend Assessment
Description
The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has agreed to participate by providing written informed consent. Subject will be eligible to participate if one of the following criteria is met: Subject has completed the 28-week double-blind phase of study D1050238 Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238 Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor. Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238. Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator. Exclusion Criteria: Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment. Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lurasidone Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
K and S Professional Research Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Woodland International Research Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Comprehensive Clinical Development Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Diligent Clinical Trials
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Synergy Clinical Research Center
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
CNS Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
AXIS Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
CNRI-Los Angeles. LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
California Neuropsychopharmacolgoy Clinical Research Insitute
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Accurate Clinical Trials
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34742
Country
United States
Facility Name
Galiz Research
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Comprehensive NeuroScience Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
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
Lousiana Clinical Research, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Center for Behavioral Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Psych Care Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Robert Lynn Horne, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CRI Worldwide LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Erie County Medical Center, Corp
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Neurobehavioral Research Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Comprehensive Clinical Development, Inc
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Oklahoma Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
CRI Worldwide LLC at Kirkbride
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Lincoln Research
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
FutureSearch Clinical Trials LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
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, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Department of Psychiatry, University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Dipartimento Salute Mentale ASL 1
City
Massa
ZIP/Postal Code
54100
Country
Italy
Facility Name
A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
City
Lipetsk
ZIP/Postal Code
398007
Country
Russian Federation
Facility Name
Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'
City
Rostov-on-Don
ZIP/Postal Code
344000
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
City
St. Peterburg
ZIP/Postal Code
191167
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
City
St. Petersburg
ZIP/Postal Code
19005
Country
Russian Federation
Facility Name
St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Military Medical Academy, Clnic for Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Mental Health
City
Dusica
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Kragujevac, Clinic for psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Centre Nis, Clinic for mental health protection
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Specialized hospital for psychiatric diseases "Sveti Vracevi"
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Facility Name
Clinical Centre Vojvodine, Clinic for Psychiatry
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie
City
Bojnice
ZIP/Postal Code
972 01
Country
Slovakia
Facility Name
Psychiatricka ambulancia Mentum s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
Psychiatricka nemocnica Michalovce n.o.
City
Michalovce
ZIP/Postal Code
071 01
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., spol. s.r.o.
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Cape Trial Centre
City
Tygervalley
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Research Unit, Department of Psychiatry Free State Psychiatric Complex
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Denmar Hospital Consulting Rooms
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

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