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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ASC-01

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC-01

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.Summed subscales are combined to compute a total score. Total score ranges from 0 to 60, with higher score indicating worse condition.

Secondary Outcome Measures

The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate

The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition. MADRS Response Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more.

The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate

The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition. MADRS Remission Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more and whose MADRS total score is 10 points or less.

The Clinical Global Impression - Improvement (CGI-I) Improvement Rate

The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. CGI-I Improvement Rate is the percentage of subjects whose CGI-I score is 1 or 2.

The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)

The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.

The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score

The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 52, with higher score indicating worse condition.

The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score

The SASS is a self-rating scale which assesses the social motivation and behavior in participants with depression. The SASS consists of 21 items covering the different aspects of social interactions, global social attitude, and self-perception. Each item is scored from 0 to 3, with higher scores indicating better condition.

The Mean Change From Baseline in the Apathy Scale (AS) Total Score

The AS consists of 14 items. Items 1-8 are scored as follows: 3= Not at all, 2= Slightly, 1= Some, 0= A lot. Items 9-14 are scored as follows: 0= Not at all, 1= Slightly, 2= Some, 3= A lot. Total score ranges from 0-42, with higher score indicating worse condition.

The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score

The MADRS-S is a patient-reported scale based on MADRS, administered to evaluate the level of depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored from 0 to 3, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 27, with higher score indicating worse condition.

Full Information

NCT ID

NCT02046564

First Posted

January 23, 2014

Last Updated

May 17, 2018

Sponsor

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02046564

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

412 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASC-01

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ASC-01

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Description

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Secondary Outcome Measure Information:

Title

The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate

Description

The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition. MADRS Response Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more.

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate

Description

The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition. MADRS Remission Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more and whose MADRS total score is 10 points or less.

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Clinical Global Impression - Improvement (CGI-I) Improvement Rate

Description

Time Frame

6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)

Description

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score

Description

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score

Description

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Mean Change From Baseline in the Apathy Scale (AS) Total Score

Description

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Title

The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score

Description

Time Frame

8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroaki Ono, Mr

Organizational Affiliation

Otsuka Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

City

Everton Park

State/Province

Queensland

Country

Australia

City

Melbourne

Country

Australia

City

Chubu Region

Country

Japan

City

Chugoku Region

Country

Japan

City

Hokkaido Region

Country

Japan

City

Kanto Region

Country

Japan

City

Kinki Region

Country

Japan

City

Kyushu Region

Country

Japan

City

Tohoku Region

Country

Japan

City

Busan

Country

Korea, Republic of

City

Chungcheongnam-do

Country

Korea, Republic of

City

Deagu

Country

Korea, Republic of

City

Gangwon-do

Country

Korea, Republic of

City

Gwangju

Country

Korea, Republic of

City

Gyeonggi-do

Country

Korea, Republic of

City

Incheon

Country

Korea, Republic of

City

Jeollabuk-do

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Ipoh

Country

Malaysia

City

Johor Bahru

Country

Malaysia

City

Kuala Lumpur

Country

Malaysia

City

Kuching

Country

Malaysia

City

Chiayi

Country

Taiwan

City

Kaohsiung

Country

Taiwan

City

Keelung

Country

Taiwan

City

Taichung

Country

Taiwan

City

Tainan

Country

Taiwan

City

Taipei

Country

Taiwan

City

Taoyuan

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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