Back to resultsMulticenter, Open-label, Safety and Tolerability Study (STEP 210)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OPC-34712
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia.
- Outpatient status at last visit of Study 331-07-203.
Exclusion Criteria:
- Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide.
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
- Subjects who during the course of their participation in 331-07-203 were treated in violation of the protocol or who developed ANY exclusion criteria during the course of their participation.
- Subjects who do not continue to meet all applicable inclusion/exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
- Subjects who represent a risk of committing suicide based on an answer of "Yes" to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A subject who has had any suicidal ideation within the last 6 months, any suicidal behaviors within the last two years, or who in the clinical judgment of the investigator presents a serious risk of suicide should be excluded from the study.
- Subjects who would be likely to require prohibited concomitant therapy during the study.
- Any subject who, in the opinion of the investigator, should not participate in the study.
Sites / Locations
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
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- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label OPDC-34712
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) During First 6 Weeks.
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Number of Participants With AEs in 52-Week Enrollers.
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Secondary Outcome Measures
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.
The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.
The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Change From Baseline in PANSS Positive Subscale Score.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Change From Baseline in PANSS Negative Subscale Score.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Percentage of Participants With a Positive Response Rate.
Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.
Percentage of Participants Who Discontinued Due to Lack of Efficacy.
Discontinuation rate for the participants discontinued due to lack of efficacy were examined.
Full Information
NCT ID
NCT01649557
First Posted
July 20, 2012
Last Updated
September 29, 2015
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01649557
Brief Title
Multicenter, Open-label, Safety and Tolerability Study
Acronym
STEP 210
Official Title
A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label OPDC-34712
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPC-34712
Intervention Description
oral administered once daily
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) During First 6 Weeks.
Description
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time Frame
From Baseline up to 6 weeks
Title
Number of Participants With AEs in 52-Week Enrollers.
Description
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time Frame
From Baseline up to 52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.
Description
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Time Frame
Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Title
Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.
Description
The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time Frame
Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Title
Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.
Description
The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Time Frame
Baseline, Week 1, 2, 6, 26, 52 and Last Visit
Title
Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.
Description
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time Frame
Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Title
Change From Baseline in PANSS Positive Subscale Score.
Description
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time Frame
Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Title
Change From Baseline in PANSS Negative Subscale Score.
Description
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time Frame
Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Title
Percentage of Participants With a Positive Response Rate.
Description
Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.
Time Frame
Last Visit
Title
Percentage of Participants Who Discontinued Due to Lack of Efficacy.
Description
Discontinuation rate for the participants discontinued due to lack of efficacy were examined.
Time Frame
Last Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia.
Outpatient status at last visit of Study 331-07-203.
Exclusion Criteria:
Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide.
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
Subjects who during the course of their participation in 331-07-203 were treated in violation of the protocol or who developed ANY exclusion criteria during the course of their participation.
Subjects who do not continue to meet all applicable inclusion/exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
Subjects who represent a risk of committing suicide based on an answer of "Yes" to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A subject who has had any suicidal ideation within the last 6 months, any suicidal behaviors within the last two years, or who in the clinical judgment of the investigator presents a serious risk of suicide should be excluded from the study.
Subjects who would be likely to require prohibited concomitant therapy during the study.
Any subject who, in the opinion of the investigator, should not participate in the study.
Facility Information:
Facility Name
Otsuka Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Otsuka Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Otsuka Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Otsuka Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Otsuka Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Otsuka Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
Otsuka Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Otsuka Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Otsuka Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Otsuka Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Otsuka Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Otsuka Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Otsuka Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Otsuka Investigational Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Otsuka Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Otsuka Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Otsuka Investigational Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Otsuka Investigational Site
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Otsuka Investigational Site
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Otsuka Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Otsuka Investigational Site
City
Radnevo
ZIP/Postal Code
6260
Country
Bulgaria
Facility Name
Otsuka Investigational Site
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Otsuka Investigational Site
City
Rijeka
ZIP/Postal Code
51 000
Country
Croatia
Facility Name
Otsuka Investigational Site
City
Zagreb
ZIP/Postal Code
10 090
Country
Croatia
Facility Name
Otsuka Investigational Site
City
Vijaywada
State/Province
Andh Prad
ZIP/Postal Code
520002
Country
India
Facility Name
Otsuka Investigational Site
City
Visakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530017
Country
India
Facility Name
Otsuka Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Otsuka Investigational Site
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560010
Country
India
Facility Name
Otsuka Investigational Site
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Otsuka Investigational Site
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575018
Country
India
Facility Name
Otsuka Investigational Site
City
Pune
State/Province
Mahara
ZIP/Postal Code
411 004
Country
India
Facility Name
Otsuka Investigational Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600003
Country
India
Facility Name
Otsuka Investigational Site
City
Varanasi
State/Province
Uttar Prad
ZIP/Postal Code
221005
Country
India
Facility Name
Otsuka Investigational Site
City
Chuncheon
ZIP/Postal Code
200-704
Country
Korea, Republic of
Facility Name
Otsuka Investigational Site
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Otsuka Investigational Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Otsuka Investigational Site
City
Seoul
ZIP/Postal Code
143-711
Country
Korea, Republic of
Facility Name
Otsuka Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Otsuka Investigational Site
City
Mandaluyong City
ZIP/Postal Code
1553
Country
Philippines
Facility Name
Otsuka Investigational Site
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Otsuka Investigational Site
City
Bucuresti 2
ZIP/Postal Code
041914
Country
Romania
Facility Name
Otsuka Investigational Site
City
Bucuresti 3
ZIP/Postal Code
041914
Country
Romania
Facility Name
Otsuka Investigational Site
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Otsuka Investigational Site
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Otsuka Investigational Site
City
Cluj - Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Otsuka Investigational Site
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Facility Name
Otsuka Investigational Site
City
Moscow Region
ZIP/Postal Code
141371
Country
Russian Federation
Facility Name
Otsuka Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Otsuka Investigational Site
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Otsuka Investigational Site
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Otsuka Investigational Site
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Otsuka Investigational Site
City
Zagorodnoye
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
Otsuka Investigational Site
City
Belgrade 2
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Otsuka Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Otsuka Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Otsuka Investigational Site
City
NoviSad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Otsuka Investigational Site
City
Bojnice
ZIP/Postal Code
92701
Country
Slovakia
Facility Name
Otsuka Investigational Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Otsuka Investigational Site
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Facility Name
Otsuka Investigational Site
City
Rimavska Sobota
ZIP/Postal Code
97912
Country
Slovakia
Facility Name
Otsuka Investigational Site
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia
Facility Name
Otsuka Investigational Site
City
Hualian
ZIP/Postal Code
981
Country
Taiwan
Facility Name
Otsuka Investigational Site
City
Taipei
ZIP/Postal Code
249
Country
Taiwan
Facility Name
Otsuka Investigational Site
City
Chernigiv
ZIP/Postal Code
14005
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Kyiv
ZIP/Postal Code
04655
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Otsuka Investigational Site
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
27188270
Citation
Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.
Results Reference
derived
Learn more about this trial
Multicenter, Open-label, Safety and Tolerability Study
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