Back to resultsStudy to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cariprazine, VRAYLAR
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with schizophrenia at least 1 year before informed consent.
- Experienced a persistent psychotic episode within 1 month prior to screening requiring treatment modifications as judged by the investigator or sub-investigator.
Exclusion Criteria:
- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
Sites / Locations
- Akita University Hospital /ID# 245941Recruiting
- IUHW Narita Hospital /ID# 243870Recruiting
- Fukuoka University Hospital /ID# 244404Recruiting
- Kuramitsu Hospital /ID# 242511Recruiting
- Shiranui Hospital /ID# 243717Recruiting
- Gifu University Hospital /ID# 246238Recruiting
- Holy Cross Hospital /ID# 242673Recruiting
- Hayakawa Clinic /ID# 242432Recruiting
- National Hospital Organization Kure Medical Center /ID# 243405Recruiting
- Goryokai Hospital /ID# 242420Recruiting
- Sapporo Medical University Hospital /ID# 245135Recruiting
- Hokkaido University Hospital /ID# 243245Recruiting
- Kagawa University Hospital /ID# 243772Recruiting
- Taniyama Hospital /ID# 242385Recruiting
- Yokohama City University Hospital /ID# 244944Recruiting
- Yuge Hospital /ID# 242849Recruiting
- University Hospital Kyoto Prefectural University of Medicine /ID# 242443Recruiting
- Maizuru Medical Center /ID# 243450Recruiting
- Mie University Hospital /ID# 244710Recruiting
- Mental Support Soyokaze Hospital /ID# 242512Recruiting
- Nara Medical University Hospital /ID# 242561Recruiting
- Asakayama General Hospital /ID# 242732Recruiting
- Hizen Psychiatric Center /ID# 243239Recruiting
- Rainbow & Sea Hospital /ID# 242699Recruiting
- Inuo Hospital /ID# 243310Recruiting
- Juntendo Univ Koshigaya Hospital /ID# 248502Recruiting
- Numazu Chuo Hospital /ID# 245275Recruiting
- Tochigi Prefectural Okamotodai Hospital /ID# 248855Recruiting
- Tokushima University Hospital /ID# 250056Recruiting
- Narimasu Kosei Hospital /ID# 243107Recruiting
- Nishigahara Hospital /ID# 243312Recruiting
- Tokyo Metropolitan Matsuzawa Hospital /ID# 245272Recruiting
- Wakayama Medical University Hospital /ID# 251105Recruiting
- Shin-abuyama Hospital /ID# 243138Recruiting
- Minamitoyama Nakagawa Hospital /ID# 243616Recruiting
- Taipei Veterans General Hospital /ID# 241522Recruiting
- Changhua Christian Hospital /ID# 241524Recruiting
- National Taiwan University Hospital - Yunlin Branch /ID# 241537Recruiting
- Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528Recruiting
- TsaoTun Psychiatric Center, MOHW /ID# 246012Recruiting
- New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653Recruiting
- Bali Psychiatric Center, MOHW /ID# 241597Recruiting
- Chung Shan Medical University Hospital /ID# 241543Recruiting
- Taichung Veterans General Hospital /ID# 246200Recruiting
- Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540Recruiting
- Taipei City Hospital, Songde Branch /ID# 241600Recruiting
- Tri-Service General Hospital Beitou Branch /ID# 241563Recruiting
- Linkou Chang Gung Memorial Hospital /ID# 241520Recruiting
- Taoyuan Psychiatric Center, MOHW /ID# 241691Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cariprazine
Placebo
Arm Description
Participants will receive cariprazine Dose A daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Secondary Outcome Measures
Change in Clinical Global Impression-Severity (CGI-S) Score
CGI-S is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.
Change in SCI-PANSS Positive Symptom Score
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score
NSA-16 is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from "not reduced" (1) to "severely reduced or absent" (6).
Change in SCI-PANSS Negative Symptom Score
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Change in SCI-PANSS Negative Factor Score
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Change in SCI-PANSS Total Score
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05368558
Brief Title
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Official Title
A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
May 9, 2025 (Anticipated)
Study Completion Date
May 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed.
Cariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. In the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. Approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across Taiwan and Japan.
Participants will receive oral capsules of cariprazine or placebo for 6 weeks. Upon completion of 6-week treatment period, participants will be eligible to receive oral capsules of cariprazine for additional 18 weeks. The safety follow up period will follow after for an additional 8 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cariprazine, VRAYLAR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cariprazine
Arm Type
Experimental
Arm Description
Participants will receive cariprazine Dose A daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
VRAYLAR
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time Frame
Up to approximately 32 Weeks
Title
Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score
Description
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Time Frame
Baseline (Week 0) through Week 6
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression-Severity (CGI-S) Score
Description
CGI-S is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.
Time Frame
Baseline (Week 0) through Week 24
Title
Change in SCI-PANSS Positive Symptom Score
Description
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Time Frame
Baseline (Week 0) through Week 24
Title
Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score
Description
NSA-16 is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from "not reduced" (1) to "severely reduced or absent" (6).
Time Frame
Baseline (Week 0) through Week 24
Title
Change in SCI-PANSS Negative Symptom Score
Description
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Time Frame
Baseline (Week 0) through Week 24
Title
Change in SCI-PANSS Negative Factor Score
Description
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Time Frame
Baseline (Week 0) through Week 24
Title
Change in SCI-PANSS Total Score
Description
SCI-PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale with responses ranging from "absent" (1) to "extreme" (7).
Time Frame
Baseline (Week 0) through Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with schizophrenia at least 1 year before informed consent.
Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator.
Exclusion Criteria:
- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Akita University Hospital /ID# 245941
City
Akita-shi
State/Province
Akita
ZIP/Postal Code
010-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
IUHW Narita Hospital /ID# 243870
City
Narita-shi
State/Province
Chiba
ZIP/Postal Code
2868520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital /ID# 244404
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kuramitsu Hospital /ID# 242511
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-0037
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shiranui Hospital /ID# 243717
City
Omuta-shi
State/Province
Fukuoka
ZIP/Postal Code
836-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital /ID# 246238
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Holy Cross Hospital /ID# 242673
City
Toki-shi
State/Province
Gifu
ZIP/Postal Code
509-5142
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hayakawa Clinic /ID# 242432
City
Kure City
State/Province
Hiroshima
ZIP/Postal Code
737-0111
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kure Medical Center /ID# 243405
City
Kure-shi
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Goryokai Hospital /ID# 242420
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
002-8029
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital /ID# 245135
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 243245
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagawa University Hospital /ID# 243772
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Taniyama Hospital /ID# 242385
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
891-0111
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Hospital /ID# 244944
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yuge Hospital /ID# 242849
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-8002
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 242443
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Maizuru Medical Center /ID# 243450
City
Maizuru
State/Province
Kyoto
ZIP/Postal Code
625-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital /ID# 244710
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mental Support Soyokaze Hospital /ID# 242512
City
Ueda-shi
State/Province
Nagano
ZIP/Postal Code
386-0401
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nara Medical University Hospital /ID# 242561
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Asakayama General Hospital /ID# 242732
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0018
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hizen Psychiatric Center /ID# 243239
City
Kanzaki-gun
State/Province
Saga
ZIP/Postal Code
842-0192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Rainbow & Sea Hospital /ID# 242699
City
Karatsu-shi
State/Province
Saga
ZIP/Postal Code
847-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inuo Hospital /ID# 243310
City
Tosu-shi
State/Province
Saga
ZIP/Postal Code
841-0081
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo Univ Koshigaya Hospital /ID# 248502
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
Numazu Chuo Hospital /ID# 245275
City
Numazu-shi
State/Province
Shizuoka
ZIP/Postal Code
4108575
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tochigi Prefectural Okamotodai Hospital /ID# 248855
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
329-1104
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokushima University Hospital /ID# 250056
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Narimasu Kosei Hospital /ID# 243107
City
Banqiao Qu
State/Province
Tokyo
ZIP/Postal Code
175-0091
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishigahara Hospital /ID# 243312
City
Kita-ku
State/Province
Tokyo
ZIP/Postal Code
114-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
156-0057
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakayama Medical University Hospital /ID# 251105
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shin-abuyama Hospital /ID# 243138
City
Takatsuki
ZIP/Postal Code
569-1041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Minamitoyama Nakagawa Hospital /ID# 243616
City
Toyama
ZIP/Postal Code
939-8073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital /ID# 241522
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital /ID# 241524
City
Changhua City, Changhua County
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital - Yunlin Branch /ID# 241537
City
Douliu City
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
City
Kaohsiung City
ZIP/Postal Code
802
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
TsaoTun Psychiatric Center, MOHW /ID# 246012
City
Nantou
ZIP/Postal Code
54249
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
City
New Taipei City
ZIP/Postal Code
236
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Bali Psychiatric Center, MOHW /ID# 241597
City
New Taipei City
ZIP/Postal Code
249
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chung Shan Medical University Hospital /ID# 241543
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital /ID# 246200
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
City
Tainan
ZIP/Postal Code
71742
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei City Hospital, Songde Branch /ID# 241600
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital Beitou Branch /ID# 241563
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 241520
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taoyuan Psychiatric Center, MOHW /ID# 241691
City
Taoyuan
ZIP/Postal Code
33058
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M22-509
Description
Related Info
Learn more about this trial
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
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