Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia (509 JPN Schz)

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 the 6-week Double-blind Period (DBP). Upon completion of 6-week DBP, participants will be eligible to receive oral capsules of Cariprazine for additional 18 weeks in the Blinded Extension Period (BEP), followed by an 8-week safety follow-up period.

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

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: Cariprazine

Detailed Description

Per the final protocol amendment 3, the number of dosing arms in the 6-week DBP of the study changed from 3 to 2. Participants enrolled in the study through Protocol Amendment 2 and who were randomized to the arm that was eliminated, remained in that arm through DBP and their data are displayed by that arm for the DBP portion of the study in participant flow, baseline characteristics and safety sections. Data for all endpoints are presented as planned per final SAP.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Takatsuki, Japan, 569-1041
    • Shin-abuyama Hospital /ID# 243138
  • Toyama, Japan, 939-8073
    • Minamitoyama Nakagawa Hospital /ID# 243616
  • Akita
    • Akita, Akita, Japan, 010-8543
      • Akita University Hospital /ID# 245941
  • Chiba
    • Narita-shi, Chiba, Japan, 2868520
      • International University of Health and Welfare Narita Hospital /ID# 243870
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital /ID# 244404
    • Fukuoka, Fukuoka, Japan, 819-0037
      • Kuramitsu Hospital /ID# 242511
    • Omuta-shi, Fukuoka, Japan, 836-0004
      • Shiranui Hospital /ID# 243717
  • Gifu
    • Gifu, Gifu, Japan, 501-1194
      • Gifu University Hospital /ID# 246238
    • Toki-shi, Gifu, Japan, 509-5142
      • Holy Cross Hospital /ID# 242673
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0111
      • Hayakawa Clinic /ID# 242432
    • Kure-shi, Hiroshima, Japan, 737-0023
      • National Hospital Organization Kure Medical Center /ID# 243405
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 002-8029
      • Goryokai Hospital /ID# 242420
    • Sapporo, Hokkaido, Japan, 060-8543
      • Sapporo Medical University Hospital /ID# 245135
    • Sapporo, Hokkaido, Japan, 060-8648
      • Duplicate_Hokkaido University Hospital /ID# 243245
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Kagawa University Hospital /ID# 243772
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 891-0111
      • Taniyama Hospital /ID# 242385
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital /ID# 244944
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 861-8002
      • Yuge Hospital /ID# 242849
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443
    • Maizuru, Kyoto, Japan, 625-8502
      • Maizuru Medical Center /ID# 243450
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital /ID# 244710
  • Nagano
    • Ueda-shi, Nagano, Japan, 386-0401
      • Mental Support Soyokaze Hospital /ID# 242512
  • Nara
    • Kashihara-shi, Nara, Japan, 634-8522
      • Nara Medical University Hospital /ID# 242561
  • Osaka
    • Sakai, Osaka, Japan, 590-0018
      • Asakayama General Hospital /ID# 242732
  • Saga-ken
    • Kanzaki-gun, Saga-ken, Japan, 842-0192
      • Hizen Psychiatric Center /ID# 243239
    • Karatsu-shi, Saga-ken, Japan, 847-0031
      • Rainbow & Sea Hospital /ID# 242699
    • Tosu-shi, Saga-ken, Japan, 841-0081
      • Inuo Hospital /ID# 243310
  • Saitama
    • Koshigaya-shi, Saitama, Japan, 343-0032
      • Juntendo Univ Koshigaya Hospital /ID# 248502
  • Shizuoka
    • Numazu-shi, Shizuoka, Japan, 4108575
      • Numazu Chuo Hospital /ID# 245275
  • Tochigi
    • Utsunomiya, Tochigi, Japan, 329-1104
      • Tochigi Prefectural Okamotodai Hospital /ID# 248855
  • Tokushima
    • Tokushima, Tokushima, Japan, 770-8503
      • Tokushima University Hospital /ID# 250056
  • Tokyo
    • Banqiao Qu, Tokyo, Japan, 175-0091
      • Narimasu Kosei Hospital /ID# 243107
    • Hachioji-shi, Tokyo, Japan, 192-0153
      • Ongata Hospital /ID# 256975
    • Kita-ku, Tokyo, Japan, 114-0024
      • Nishigahara Hospital /ID# 243312
    • Kodaira-shi, Tokyo, Japan, 187-8551
      • National Center of Neurology and Psychiatry /ID# 242677
    • Setagaya-ku, Tokyo, Japan, 156-0057
      • Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital /ID# 251105
• Taiwan
  • Changhua City, Changhua County, Taiwan, 50006
    • Changhua Christian Hospital /ID# 241524
  • Douliu, Taiwan, 640
    • National Taiwan University Hospital - Yunlin Branch /ID# 241537
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
  • Nantou City, Taiwan, 54249
    • TsaoTun Psychiatric Center, MOHW /ID# 246012
  • New Taipei City, Taiwan, 236
    • New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital /ID# 241543
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 246200
  • Tainan City, Taiwan, 71742
    • Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
  • Taipei, Taiwan, 112
    • Tri-Service General Hospital Beitou Branch /ID# 241563
  • Taipei, Taiwan, 110
    • Taipei City Hospital, Songde Branch /ID# 241600
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 241520
  • Taoyuan District, Taiwan, 33058
    • Taoyuan Psychiatric Center, MOHW /ID# 241691
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 802
      • Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
  • New Taipei
    • New Taipei City, New Taipei, Taiwan, 249
      • Bali Psychiatric Center /ID# 241597
  • Taipei
    • Taipei City, Taipei, Taiwan, 11217
      • Taipei Veterans General Hospital /ID# 241522

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

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.	Drug: Cariprazine; Oral Capsule; Other Names: VRAYLAR
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.	Drug: Placebo; Oral Capsule; Drug: Cariprazine; Oral Capsule; Other Names: VRAYLAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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 drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CGI-S Score From Baseline (Wk 0) to Week 6	Clinical Global Impression-Severity (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 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.	Baseline (Wk 0) to Week 6
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) to Week 6
Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6	Negative Symptom Assessment-16 (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 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.	Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) to Week 6
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) and Week 6 to Week 24
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24	Clinical Global Impression-Severity (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 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.	Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) and Week 6 to Week 24
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24	Negative Symptom Assessment-16 (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 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.	Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24	Structured Clinical Interview for the Positive and Negative Syndrome Scale (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 scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.	Baseline (Wk 0) and Week 6 to Week 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Cariprazine; VRAYLAR
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; cariprazine
• Other Study ID Numbers: M22-509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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