Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

NCT ID: NCT02046564

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-09-30

Brief Summary

To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASC-01

The dose of 3-12mg/100mg(Aripiprazole/Sertraline Combination)will be orally administered once daily

Group Type: EXPERIMENTAL

ASC-01

Intervention Type: DRUG

Placebo

The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

ASC-01

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who are either inpatients or outpatients.
• Patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial.
• Patients who have been given a diagnosis of "Major Depressive Disorder, Single Episode" or "Major Depressive Disorder, Recurrent" according to the DSM-5 and who have a current episode of major depression that has been continuing for at least 8 weeks
• Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation

Exclusion Criteria

• Female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial
• Pregnant or breast-feeding female patients, or female patients who may be pregnant
• Patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
• Patients who have had electroconvulsive therapy
• Patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
• Patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms)
• Patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic

• fasting blood glucose level ≥ 126 mg/dL
• 2-hour glucose level in 75-g oral glucose tolerance test (OGTT) ≥ 200 mg/dL
• non-fasting blood glucose level ≥ 200 mg/dL
• HbA1c [NGSP level] ≥ 6.5%
• Patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent)
• Patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
• Patients who have a history of seizure disorder (eg, epilepsy)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Ono, Mr

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Everton Park, Queensland, Australia

Melbourne, , Australia

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Tohoku Region, , Japan

Ipoh, , Malaysia

Johor Bahru, , Malaysia

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Busan, , South Korea

Chungcheongnam-do, , South Korea

Deagu, , South Korea

Gangwon-do, , South Korea

Gwangju, , South Korea

Gyeonggi-do, , South Korea

Incheon, , South Korea

Jeollabuk-do, , South Korea

Seoul, , South Korea

Chiayi City, , Taiwan

Kaohsiung City, , Taiwan

Keelung, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

Australia; Japan; Malaysia; South Korea; Taiwan

Other Identifiers

JapicCTI-142413

Identifier Type: OTHER

Identifier Source: secondary_id

031-12-005

Identifier Type: -

Identifier Source: org_study_id