Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

March 25, 2024 updated by: AbbVie

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

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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.
Oral Capsule
Oral Capsule
Other Names:
  • VRAYLAR

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2022

Primary Completion (Estimated)

May 9, 2025

Study Completion (Estimated)

August 11, 2034

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)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 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

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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