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

NCT05368558 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: M22-509
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 52

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Cariprazine; VRAYLAR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Change in CGI-S Score From Baseline (Wk 0) to Week 6

  Baseline (Wk 0) to Week 6

• Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6

  Baseline (Wk 0) to Week 6

• Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6

  Baseline (Wk 0) to Week 6

• Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6

  Baseline (Wk 0) to Week 6

• Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6

  Baseline (Wk 0) to Week 6

Study Arms (2)

Cariprazine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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: Cariprazine; Drug: Placebo

Interventions

Cariprazine DRUG

Oral Capsule

Also known as: VRAYLAR

Cariprazine; Placebo

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (52)

Akita University Hospital /ID# 245941

Akita, Akita, 010-8543, Japan

Location

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

Narita-shi, Chiba, 2868520, Japan

Location

Fukuoka University Hospital /ID# 244404

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kuramitsu Hospital /ID# 242511

Fukuoka, Fukuoka, 819-0037, Japan

Location

Shiranui Hospital /ID# 243717

Omuta-shi, Fukuoka, 836-0004, Japan

Location

Gifu University Hospital /ID# 246238

Gifu, Gifu, 501-1194, Japan

Location

Holy Cross Hospital /ID# 242673

Toki-shi, Gifu, 509-5142, Japan

Location

Hayakawa Clinic /ID# 242432

Kure, Hiroshima, 737-0111, Japan

Location

National Hospital Organization Kure Medical Center /ID# 243405

Kure-shi, Hiroshima, 737-0023, Japan

Location

Goryokai Hospital /ID# 242420

Sapporo, Hokkaido, 002-8029, Japan

Location

Sapporo Medical University Hospital /ID# 245135

Sapporo, Hokkaido, 060-8543, Japan

Location

Duplicate_Hokkaido University Hospital /ID# 243245

Sapporo, Hokkaido, 060-8648, Japan

Location

Kagawa University Hospital /ID# 243772

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Taniyama Hospital /ID# 242385

Kagoshima, Kagoshima-ken, 891-0111, Japan

Location

Yokohama City University Hospital /ID# 244944

Yokohama, Kanagawa, 236-0004, Japan

Location

Yuge Hospital /ID# 242849

Kumamoto, Kumamoto, 861-8002, Japan

Location

Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443

Kyoto, Kyoto, 602-8566, Japan

Location

Maizuru Medical Center /ID# 243450

Maizuru, Kyoto, 625-8502, Japan

Location

Mie University Hospital /ID# 244710

Tsu, Mie-ken, 514-8507, Japan

Location

Mental Support Soyokaze Hospital /ID# 242512

Ueda-shi, Nagano, 386-0401, Japan

Location

Nara Medical University Hospital /ID# 242561

Kashihara-shi, Nara, 634-8522, Japan

Location

Asakayama General Hospital /ID# 242732

Sakai, Osaka, 590-0018, Japan

Location

Hizen Psychiatric Center /ID# 243239

Kanzaki-gun, Saga-ken, 842-0192, Japan

Location

Rainbow & Sea Hospital /ID# 242699

Karatsu-shi, Saga-ken, 847-0031, Japan

Location

Inuo Hospital /ID# 243310

Tosu-shi, Saga-ken, 841-0081, Japan

Location

Juntendo Univ Koshigaya Hospital /ID# 248502

Koshigaya-shi, Saitama, 343-0032, Japan

Location

Numazu Chuo Hospital /ID# 245275

Numazu-shi, Shizuoka, 4108575, Japan

Location

Tochigi Prefectural Okamotodai Hospital /ID# 248855

Utsunomiya, Tochigi, 329-1104, Japan

Location

Tokushima University Hospital /ID# 250056

Tokushima, Tokushima, 770-8503, Japan

Location

Narimasu Kosei Hospital /ID# 243107

Banqiao Qu, Tokyo, 175-0091, Japan

Location

Ongata Hospital /ID# 256975

Hachioji-shi, Tokyo, 192-0153, Japan

Location

Nishigahara Hospital /ID# 243312

Kita-ku, Tokyo, 114-0024, Japan

Location

National Center of Neurology and Psychiatry /ID# 242677

Kodaira-shi, Tokyo, 187-8551, Japan

Location

Tokyo Metropolitan Matsuzawa Hospital /ID# 245272

Setagaya-ku, Tokyo, 156-0057, Japan

Location

Wakayama Medical University Hospital /ID# 251105

Wakayama, Wakayama, 641-8510, Japan

Location

Shin-abuyama Hospital /ID# 243138

Takatsuki, 569-1041, Japan

Location

Minamitoyama Nakagawa Hospital /ID# 243616

Toyama, 939-8073, Japan

Location

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533

Kaohsiung City, Kaohsiung, 802, Taiwan

Location

Bali Psychiatric Center /ID# 241597

New Taipei City, New Taipei, 249, Taiwan

Location

Taipei Veterans General Hospital /ID# 241522

Taipei City, Taipei, 11217, Taiwan

Location

Changhua Christian Hospital /ID# 241524

Changhua City, Changhua County, 50006, Taiwan

Location

National Taiwan University Hospital - Yunlin Branch /ID# 241537

Douliu, 640, Taiwan

Location

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

Kaohsiung City, 807, Taiwan

Location

TsaoTun Psychiatric Center, MOHW /ID# 246012

Nantou City, 54249, Taiwan

Location

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

New Taipei City, 236, Taiwan

Location

Chung Shan Medical University Hospital /ID# 241543

Taichung, 40201, Taiwan

Location

Taichung Veterans General Hospital /ID# 246200

Taichung, 40705, Taiwan

Location

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

Tainan, 71742, Taiwan

Location

Taipei City Hospital, Songde Branch /ID# 241600

Taipei, 110, Taiwan

Location

Tri-Service General Hospital Beitou Branch /ID# 241563

Taipei, 112, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 241520

Taoyuan, 333, Taiwan

Location

Taoyuan Psychiatric Center, MOHW /ID# 241691

Taoyuan District, 33058, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: August 18, 2022
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (37); TW (15)