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

NCT ID: NCT05368558

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-18
• Study Completion Date: 2024-09-20

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 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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cariprazine

Intervention Type: DRUG

Oral Capsule

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.

Group Type: PLACEBO_COMPARATOR

Cariprazine

Intervention Type: DRUG

Oral Capsule

Placebo

Intervention Type: DRUG

Oral Capsule

Interventions

Cariprazine

Oral Capsule

Intervention Type: DRUG

Placebo

Oral Capsule

Intervention Type: DRUG

Other Intervention Names

VRAYLAR

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Akita University Hospital /ID# 245941

Akita, Akita, Japan

International University of Health and Welfare Narita Hospital /ID# 243870

Narita-shi, Chiba, Japan

Fukuoka University Hospital /ID# 244404

Fukuoka, Fukuoka, Japan

Kuramitsu Hospital /ID# 242511

Fukuoka, Fukuoka, Japan

Shiranui Hospital /ID# 243717

Omuta-shi, Fukuoka, Japan

Gifu University Hospital /ID# 246238

Gifu, Gifu, Japan

Holy Cross Hospital /ID# 242673

Toki-shi, Gifu, Japan

Hayakawa Clinic /ID# 242432

Kure, Hiroshima, Japan

National Hospital Organization Kure Medical Center /ID# 243405

Kure-shi, Hiroshima, Japan

Goryokai Hospital /ID# 242420

Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital /ID# 245135

Sapporo, Hokkaido, Japan

Duplicate_Hokkaido University Hospital /ID# 243245

Sapporo, Hokkaido, Japan

Kagawa University Hospital /ID# 243772

Kita-gun, Kagawa-ken, Japan

Taniyama Hospital /ID# 242385

Kagoshima, Kagoshima-ken, Japan

Yokohama City University Hospital /ID# 244944

Yokohama, Kanagawa, Japan

Yuge Hospital /ID# 242849

Kumamoto, Kumamoto, Japan

Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443

Kyoto, Kyoto, Japan

Maizuru Medical Center /ID# 243450

Maizuru, Kyoto, Japan

Mie University Hospital /ID# 244710

Tsu, Mie-ken, Japan

Mental Support Soyokaze Hospital /ID# 242512

Ueda-shi, Nagano, Japan

Nara Medical University Hospital /ID# 242561

Kashihara-shi, Nara, Japan

Asakayama General Hospital /ID# 242732

Sakai, Osaka, Japan

Hizen Psychiatric Center /ID# 243239

Kanzaki-gun, Saga-ken, Japan

Rainbow & Sea Hospital /ID# 242699

Karatsu-shi, Saga-ken, Japan

Inuo Hospital /ID# 243310

Tosu-shi, Saga-ken, Japan

Juntendo Univ Koshigaya Hospital /ID# 248502

Koshigaya-shi, Saitama, Japan

Numazu Chuo Hospital /ID# 245275

Numazu-shi, Shizuoka, Japan

Tochigi Prefectural Okamotodai Hospital /ID# 248855

Utsunomiya, Tochigi, Japan

Tokushima University Hospital /ID# 250056

Tokushima, Tokushima, Japan

Narimasu Kosei Hospital /ID# 243107

Banqiao Qu, Tokyo, Japan

Ongata Hospital /ID# 256975

Hachioji-shi, Tokyo, Japan

Nishigahara Hospital /ID# 243312

Kita-ku, Tokyo, Japan

National Center of Neurology and Psychiatry /ID# 242677

Kodaira-shi, Tokyo, Japan

Tokyo Metropolitan Matsuzawa Hospital /ID# 245272

Setagaya-ku, Tokyo, Japan

Wakayama Medical University Hospital /ID# 251105

Wakayama, Wakayama, Japan

Shin-abuyama Hospital /ID# 243138

Takatsuki, , Japan

Minamitoyama Nakagawa Hospital /ID# 243616

Toyama, , Japan

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533

Kaohsiung City, Kaohsiung, Taiwan

Bali Psychiatric Center /ID# 241597

New Taipei City, New Taipei, Taiwan

Taipei Veterans General Hospital /ID# 241522

Taipei City, Taipei, Taiwan

Changhua Christian Hospital /ID# 241524

Changhua City, Changhua County, , Taiwan

National Taiwan University Hospital - Yunlin Branch /ID# 241537

Douliu, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528

Kaohsiung City, , Taiwan

TsaoTun Psychiatric Center, MOHW /ID# 246012

Nantou City, , Taiwan

New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653

New Taipei City, , Taiwan

Chung Shan Medical University Hospital /ID# 241543

Taichung, , Taiwan

Taichung Veterans General Hospital /ID# 246200

Taichung, , Taiwan

Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540

Tainan City, , Taiwan

Taipei City Hospital, Songde Branch /ID# 241600

Taipei, , Taiwan

Tri-Service General Hospital Beitou Branch /ID# 241563

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital /ID# 241520

Taoyuan, , Taiwan

Taoyuan Psychiatric Center, MOHW /ID# 241691

Taoyuan District, , Taiwan

Countries

Japan; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M22-509

Related Info

Other Identifiers

M22-509

Identifier Type: -

Identifier Source: org_study_id