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Clinical Trials List

Protocol NumberM22-509
NCT Number(ClinicalTrials.gov Identfier)NCT05368558
Completed

2022-07-01 - 2024-09-20

Phase III

Not yet recruiting3

Recruiting11

Terminated2

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

  • Trial Applicant

    AbbVie

  • Sponsor

    ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator cheng sheng Chen Division of Psychiatry
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Li 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 朱柏全 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馬家豪 無
National Taiwan University Hospital Yunlin Branch 

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator NAN-YING CHIU 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳建志 無
Taoyuan Psychiatric Center,MOHW

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃卓尹 無
Taipei City Hospital Songde Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃正誼 無
Psychiatric Center,MOHW

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 謝建宏 無
Jianan Psychiatric Center,MOHW

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李典政 無
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 吳永富 無
Tri-Service General Hospital Beitou Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林志堅 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 藍祚鴻 無
衛生福利部草屯療養院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林皇利 Division of Psychiatry
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳永富 無
國防醫學大學三軍總醫院北投分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 馬家豪 無
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Schizophrenia

Objectives

To assess the efficacy, safety, and tolerability of cariprazine in comparison to placebo in subjects from Japan and Taiwan with acute exacerbation of schizophrenia.

Test Drug

Cariprazine

Active Ingredient

Dosage Form

Dosage

N/A

Endpoints

1.To assess the efficacy, safety, and tolerability of cariprazine in comparison to placebo in
subjects from Japan and Taiwan with acute exacerbation of schizophrenia.
2.Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale
(SCI-PANSS) total score from baseline to double-blind period (DBP) Week 6.

Inclution Criteria

1.Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
2.Diagnosed with schizophrenia at least 1 year before informed consent.Experienced a persistent psychotic episode within 1 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.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    250 participants

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