- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05368558
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
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
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: ABBVIE CALL CENTER
- Phone Number: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Study Locations
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Takatsuki, Japan, 569-1041
- Recruiting
- Shin-abuyama Hospital /ID# 243138
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Toyama, Japan, 939-8073
- Recruiting
- Minamitoyama Nakagawa Hospital /ID# 243616
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Akita
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Akita-shi, Akita, Japan, 010-8543
- Recruiting
- Akita University Hospital /ID# 245941
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Chiba
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Narita-shi, Chiba, Japan, 2868520
- Recruiting
- IUHW Narita Hospital /ID# 243870
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 819-0037
- Recruiting
- Kuramitsu Hospital /ID# 242511
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Fukuoka-shi, Fukuoka, Japan, 814-0180
- Recruiting
- Fukuoka University Hospital /ID# 244404
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Omuta-shi, Fukuoka, Japan, 836-0004
- Recruiting
- Shiranui Hospital /ID# 243717
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Gifu
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Gifu-shi, Gifu, Japan, 501-1194
- Recruiting
- Gifu University Hospital /ID# 246238
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Toki-shi, Gifu, Japan, 509-5142
- Recruiting
- Holy Cross Hospital /ID# 242673
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Hiroshima
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Kure City, Hiroshima, Japan, 737-0111
- Recruiting
- Hayakawa Clinic /ID# 242432
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Kure-shi, Hiroshima, Japan, 737-0023
- Recruiting
- National Hospital Organization Kure Medical Center /ID# 243405
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 002-8029
- Recruiting
- Goryokai Hospital /ID# 242420
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Sapporo-shi, Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital /ID# 243245
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Sapporo-shi, Hokkaido, Japan, 060-8543
- Recruiting
- Sapporo Medical University Hospital /ID# 245135
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Kagawa
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Kita-gun, Kagawa, Japan, 761-0793
- Completed
- Kagawa University Hospital /ID# 243772
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 891-0111
- Recruiting
- Taniyama Hospital /ID# 242385
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Kanagawa
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Yokohama-shi, Kanagawa, Japan, 236-0004
- Recruiting
- Yokohama City University Hospital /ID# 244944
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan, 861-8002
- Recruiting
- Yuge Hospital /ID# 242849
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Kyoto
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Kyoto-shi, Kyoto, Japan, 602-8566
- Recruiting
- University Hospital Kyoto Prefectural University of Medicine /ID# 242443
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Maizuru, Kyoto, Japan, 625-8502
- Recruiting
- Maizuru Medical Center /ID# 243450
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Mie
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Tsu-shi, Mie, Japan, 514-8507
- Recruiting
- Mie University Hospital /ID# 244710
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Nagano
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Ueda-shi, Nagano, Japan, 386-0401
- Recruiting
- Mental Support Soyokaze Hospital /ID# 242512
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Nara
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Kashihara-shi, Nara, Japan, 634-8522
- Recruiting
- Nara Medical University Hospital /ID# 242561
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Osaka
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Sakai, Osaka, Japan, 590-0018
- Recruiting
- Asakayama General Hospital /ID# 242732
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Saga
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Kanzaki-gun, Saga, Japan, 842-0192
- Recruiting
- Hizen Psychiatric Center /ID# 243239
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Karatsu-shi, Saga, Japan, 847-0031
- Recruiting
- Rainbow & Sea Hospital /ID# 242699
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Tosu-shi, Saga, Japan, 841-0081
- Recruiting
- Inuo Hospital /ID# 243310
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Saitama
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Koshigaya-shi, Saitama, Japan, 343-0032
- Recruiting
- Juntendo Univ Koshigaya Hospital /ID# 248502
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Shizuoka
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Numazu-shi, Shizuoka, Japan, 4108575
- Recruiting
- Numazu Chuo Hospital /ID# 245275
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Tochigi
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Utsunomiya-shi, Tochigi, Japan, 329-1104
- Recruiting
- Tochigi Prefectural Okamotodai Hospital /ID# 248855
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Tokushima
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Tokushima-shi, Tokushima, Japan, 770-8503
- Recruiting
- Tokushima University Hospital /ID# 250056
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Tokyo
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Banqiao Qu, Tokyo, Japan, 175-0091
- Recruiting
- Narimasu Kosei Hospital /ID# 243107
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Hachioji-shi, Tokyo, Japan, 192-0153
- Recruiting
- Ongata Hospital /ID# 256975
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Kita-ku, Tokyo, Japan, 114-0024
- Recruiting
- Nishigahara Hospital /ID# 243312
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Kodaira-shi, Tokyo, Japan, 187-8551
- Recruiting
- National Center of Neurology and Psychiatry /ID# 242677
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Setagaya-ku, Tokyo, Japan, 156-0057
- Recruiting
- Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
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Wakayama
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Wakayama-shi, Wakayama, Japan, 641-8510
- Recruiting
- Wakayama Medical University Hospital /ID# 251105
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Changhua City, Changhua County, Taiwan, 50006
- Recruiting
- Changhua Christian Hospital /ID# 241524
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Douliu City, Taiwan, 640
- Recruiting
- National Taiwan University Hospital - Yunlin Branch /ID# 241537
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Kaohsiung, Taiwan, 807
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
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Kaohsiung City, Taiwan, 802
- Recruiting
- Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
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Nantou, Taiwan, 54249
- Recruiting
- TsaoTun Psychiatric Center, MOHW /ID# 246012
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New Taipei City, Taiwan, 236
- Recruiting
- New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
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New Taipei City, Taiwan, 249
- Recruiting
- Bali Psychiatric Center, MOHW /ID# 241597
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Taichung, Taiwan, 40201
- Recruiting
- Chung Shan Medical University Hospital /ID# 241543
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Taichung, Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital /ID# 246200
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Tainan, Taiwan, 71742
- Recruiting
- Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
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Taipei, Taiwan, 112
- Recruiting
- Tri-Service General Hospital Beitou Branch /ID# 241563
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Taipei City, Taiwan, 110
- Recruiting
- Taipei City Hospital, Songde Branch /ID# 241600
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Taoyuan, Taiwan, 33058
- Recruiting
- Taoyuan Psychiatric Center, MOHW /ID# 241691
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Taoyuan City, Taiwan, 333
- Recruiting
- Linkou Chang Gung Memorial Hospital /ID# 241520
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Taipei
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Taipei City, Taipei, Taiwan, 11217
- Recruiting
- Taipei Veterans General Hospital /ID# 241522
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cariprazine
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.
|
Oral Capsule
Other Names:
|
Placebo Comparator: Placebo
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.
|
Oral Capsule
Oral Capsule
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Adverse Events
Time Frame: Up to approximately 32 Weeks
|
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.
|
Up to approximately 32 Weeks
|
Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score
Time Frame: Baseline (Week 0) through Week 6
|
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).
|
Baseline (Week 0) through Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clinical Global Impression-Severity (CGI-S) Score
Time Frame: Baseline (Week 0) through Week 24
|
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.
|
Baseline (Week 0) through Week 24
|
Change in SCI-PANSS Positive Symptom Score
Time Frame: Baseline (Week 0) through Week 24
|
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).
|
Baseline (Week 0) through Week 24
|
Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score
Time Frame: Baseline (Week 0) through Week 24
|
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).
|
Baseline (Week 0) through Week 24
|
Change in SCI-PANSS Negative Symptom Score
Time Frame: Baseline (Week 0) through Week 24
|
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).
|
Baseline (Week 0) through Week 24
|
Change in SCI-PANSS Negative Factor Score
Time Frame: Baseline (Week 0) through Week 24
|
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).
|
Baseline (Week 0) through Week 24
|
Change in SCI-PANSS Total Score
Time Frame: Baseline (Week 0) through Week 24
|
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).
|
Baseline (Week 0) through Week 24
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M22-509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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