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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05368558
Collaborator
(none)
402
Enrollment
48
Locations
3
Arms
34.5
Anticipated Duration (Months)
8.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Approximately 402 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 75 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 28, 2022
Anticipated Primary Completion Date :
May 9, 2025
Anticipated Study Completion Date :
May 12, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cariprazine Dose A

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 A for 18 weeks.

Drug: Cariprazine
Oral Capsule
Other Names:
  • VRAYLAR

    		•
    Experimental: Cariprazine Dose B

    Participants will receive cariprazine Dose B 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 C for 18 weeks.

    Drug: Cariprazine
    Oral Capsule
    Other Names:
  • VRAYLAR

    • Drug: Placebo
    Oral Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Experiencing Adverse Events [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.

    2. Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Total Score [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).

    Secondary Outcome Measures

    1. Change in Clinical Global Impression-Severity (CGI-S) Score [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.

    2. Change in SCI-PANSS Positive Symptom Score [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).

    3. Change in 16-Item Negative Symptom Assessment (NSA-16) Total Score [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).

    4. Change in SCI-PANSS Negative Symptom Score [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).

    5. Change in SCI-PANSS Negative Factor Score [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).

    6. Change in SCI-PANSS Total Score [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with schizophrenia at least 1 year before informed consent.

    • Experienced a persistent psychotic episode within 1 month prior to screening 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akita University Hospital /ID# 245941 Akita-shi Akita Japan 010-8543
    2 IUHW Narita Hospital /ID# 243870 Narita-shi Chiba Japan 2868520
    3 Kuramitsu Hospital /ID# 242511 Fukuoka-shi Fukuoka Japan 819-0037
    4 Shiranui Hospital /ID# 243717 Omuta-shi Fukuoka Japan 836-0004
    5 Gifu University Hospital /ID# 246238 Gifu-shi Gifu Japan 501-1194
    6 Holy Cross Hospital /ID# 242673 Toki-shi Gifu Japan 509-5142
    7 Hayakawa Clinic /ID# 242432 Kure City Hiroshima Japan 737-0111
    8 National Hospital Organization Kure Medical Center /ID# 243405 Kure-shi Hiroshima Japan 737-0023
    9 Goryokai Hospital /ID# 242420 Sapporo-shi Hokkaido Japan 002-8029
    10 Sapporo Medical University Hospital /ID# 245135 Sapporo-shi Hokkaido Japan 060-8543
    11 Hokkaido University Hospital /ID# 243245 Sapporo-shi Hokkaido Japan 060-8648
    12 Kagawa University Hospital /ID# 243772 Kita-gun Kagawa Japan 761-0793
    13 Taniyama Hospital /ID# 242385 Kagoshima-shi Kagoshima Japan 891-0111
    14 Yokohama City University Hospital /ID# 244944 Yokohama-shi Kanagawa Japan 236-0004
    15 Yuge Hospital /ID# 242849 Kumamoto-shi Kumamoto Japan 861-8002
    16 University Hospital Kyoto Prefectural University of Medicine /ID# 242443 Kyoto-shi Kyoto Japan 602-8566
    17 Maizuru Medical Center /ID# 243450 Maizuru Kyoto Japan 625-8502
    18 Mie University Hospital /ID# 244710 Tsu-shi Mie Japan 514-8507
    19 Mental Support Soyokaze Hospital /ID# 242512 Ueda-shi Nagano Japan 386-0401
    20 Nara Medical University Hospital /ID# 242561 Kashihara-shi Nara Japan 634-8522
    21 Asakayama General Hospital /ID# 242732 Sakai Osaka Japan 590-0018
    22 Hizen Psychiatric Center /ID# 243239 Kanzaki-gun Saga Japan 842-0192
    23 Rainbow & Sea Hospital /ID# 242699 Karatsu-shi Saga Japan 847-0031
    24 Inuo Hospital /ID# 243310 Tosu-shi Saga Japan 841-0081
    25 Numazu Chuo Hospital /ID# 245275 Numazu-shi Shizuoka Japan 4108575
    26 Narimasu Kosei Hospital /ID# 243107 Banqiao Qu Tokyo Japan 175-0091
    27 Katsushikabashi Hospital /ID# 243407 Katsushika-ku Tokyo Japan 125-0041
    28 Nishigahara Hospital /ID# 243312 Kita-ku Tokyo Japan 114-0024
    29 Tokyo Metropolitan Matsuzawa Hospital /ID# 245272 Setagaya-ku Tokyo Japan 156-0057
    30 Okitama Public General Hospital /ID# 243210 Higashiokitama-gun Yamagata Japan 992-0601
    31 National Hospital Organization Shimofusa Psychiatric Medical Center /ID# 242477 Chiba Japan 266-0007
    32 Shin-abuyama Hospital /ID# 243138 Takatsuki Japan 569-1041
    33 Minamitoyama Nakagawa Hospital /ID# 243616 Toyama Japan 939-8073
    34 Taipei Veterans General Hospital /ID# 241522 Taipei City Taipei Taiwan 11217
    35 Changhua Christian Hospital /ID# 241524 Changhua City, Changhua County Taiwan 50006
    36 National Taiwan University Hospital - Yunlin Branch /ID# 241537 Douliu City Taiwan 640
    37 Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533 Kaohsiung City Taiwan 802
    38 Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528 Kaohsiung Taiwan 807
    39 TsaoTun Psychiatric Center, MOHW /ID# 246012 Nantou Taiwan 54249
    40 New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653 New Taipei City Taiwan 236
    41 Bali Psychiatric Center, MOHW /ID# 241597 New Taipei City Taiwan 249
    42 Chung Shan Medical University Hospital /ID# 241543 Taichung Taiwan 40201
    43 Taichung Veterans General Hospital /ID# 246200 Taichung Taiwan 40705
    44 Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540 Tainan Taiwan 71742
    45 Taipei City Hospital, Songde Branch /ID# 241600 Taipei City Taiwan 110
    46 Tri-Service General Hospital Beitou Branch /ID# 241563 Taipei Taiwan 11243
    47 Linkou Chang Gung Memorial Hospital /ID# 241520 Taoyuan City Taiwan 333
    48 Taoyuan Psychiatric Center, MOHW /ID# 241691 Taoyuan Taiwan 33058

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05368558
    Other Study ID Numbers:
    • M22-509
    First Posted:
    May 10, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Schizophrenia
    Cariprazine
    VRAYLAR
    Additional relevant MeSH terms:
    Schizophrenia
    Cariprazine

    Study Results

    No Results Posted as of Aug 16, 2022