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Clinical Trials List

Protocol NumberRGH-MD-25

2019-09-01 - 2022-09-22

Phase III

Not yet recruiting1

Recruiting4

ICD-10F31.70

Bipolar disorder, currently in remission, most recent episode unspecified

ICD-10F31.71

Bipolar disorder, in partial remission, most recent episode hypomanic

ICD-10F31.72

Bipolar disorder, in full remission, most recent episode hypomanic

ICD-10F31.9

Bipolar disorder, unspecified

ICD-9296.7

Bipolar affective disorder, unspecified

A double-blind, placebo-controlled,randomized withdrawal, multicenter clinical trial evaluating the efficacy, safety, and tolerability of cariprazine in a dose-reduction paradigm in the prevention of relapse in bipolar I disorder patients whose current episode is manic or depressive, with or without mixed features

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Allergan

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Hsien-Yuan Lane Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yen-Kwuan Yang Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chin-Bin Yeh Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳益乾 Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Cheng-Ta Li Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Bipolar I disorder

Objectives

To evaluate the efficacy, safety, and tolerability of cariprazine in a dose-reduction paradigm in the prevention of relapse in bipolar I disorder patients whose current episode is manic or depressive, with or without mixed features

Test Drug

Cariprazine

Active Ingredient

Cariprazine

Dosage Form

Capsule

Dosage

1.5 or 3

Endpoints

None

Inclution Criteria

None

Exclusion Criteria

None

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    822 participants