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Clinical Trials List

Protocol Number031-12-005

NCT Number(ClinicalTrials.gov Identfier)NCT02046564

2013-12-18 - 2015-10-31

Phase III

Terminated12

A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients with Major Depressive Disorder

Trial Applicant

PAREXEL INTERNATIONAL CO., LTD.
Sponsor

Otsuka Pharmaceutical Co., Ltd.
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Hsien-Yuan Lane Division of Psychiatry

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Principal Investigator HSIN-CHIEN LEE Division of Psychiatry

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 侯育銘 Division of Psychiatry

Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳志根 Division of Psychiatry

Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chia-Yi Liu Division of Psychiatry

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 方俊凱 Division of Psychiatry

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 沈裕智 Division of Psychiatry

Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林式穀 Division of Psychiatry

Taipei City Hospital Songde Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chin-Bin Yeh Division of Psychiatry

Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

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 Terminated

Principal Investigator Yen-Kwuan Yang Division of Psychiatry

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 方俊凱 Division of Psychiatry

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Major depressive disorder

Objectives

To assess the efficacy and safety of ASC-01 in patients with major depressive disorder

Test Drug

ASC-01

Active Ingredient

aripiprazole/sertraline

Dosage Form

tablet

Dosage

12/100
3/100
6/100
9/100

Endpoints

MADRS, CGI, CGI-S, HAM-D, SASS, AS, MADRS-S, ECG, DIEPSS, AIMS, BAS, and C -SSRS

Inclution Criteria

Major depressive disorder

Exclusion Criteria

According to DSM-5
 Neurocognitive Disorders
 Schizophrenia Spectrum, and Other Psychotic Disorders
 Bipolar and Related Disorders
 Feeding and Eating Disorders
 Obsessive-Compulsive Disorders
 Panic Disorder
 Posttraumatic Stress Disorder
 Substance-Related Disorders
 Personality Disorder

The Estimated Number of Participants

Taiwan

11 participants
Global

800 participants