Assess the Efficacy and Safety of ASC-01 in Patients With... | NCT02046564

ID	Type	Description	Link
JapicCTI-142413	Other Identifier	Japic

Status Module

Label	Type	Description	Intervention Names
ASC-01	Experimental	The dose of 3-12mg/100mg(Aripiprazole/Sertraline Combination)will be orally administered once daily	Drug: ASC-01
Placebo	Placebo Comparator	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ASC-01	Drug		ASC-01
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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)

Name	Affiliation	Role
Hiroaki Ono, Mr	Otsuka Pharmaceutical Co., Ltd.	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
BG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038.3± 11.8 BG00139.5± 11.8 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00079 BG00172 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

South Korea

Title	Measurements
	BG00036 BG00142 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Error

units on a scale

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Units	Counts
Participants	OG000208 OG001203

Title

Denominators

Categories

Title	Measurements
	OG000-9.2± 0.5 OG001-7.2± 0.5

Secondary

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

MADRS Response Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more.

Posted

Number

percentage of participants

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Secondary

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

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.

Posted

Number

percentage of participants

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Secondary

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.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Secondary

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.

Posted

Mean

Standard Error

units on a scale

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Secondary

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.

Posted

Mean

Standard Error

units on a scale

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Secondary

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.

Posted

Mean

Standard Error

units on a scale

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Secondary

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.

Posted

Mean

Standard Error

units on a scale

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Units

Secondary

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.

Posted

Mean

Standard Error

units on a scale

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])

ID	Title	Description
OG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.
OG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ASC-01	Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6.	0	209	0	209	128	209
EG001	Placebo	The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.	0	203	2	203	107	203

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0005 affected209 at risk EG0014 affected203 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0002 affected209 at risk EG0014 affected203 at risk
Nausea	Gastrointestinal disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0009 affected209 at risk EG00110 affected203 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0001 affected209 at risk EG0014 affected203 at risk
Vomiting	Gastrointestinal disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0005 affected209 at risk EG0013 affected203 at risk
Drug withdrawal syndrome	General disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0005 affected209 at risk EG0013 affected203 at risk
Nasopharyngitis	Infections and infestations	MedDRA Ver. 19.0	Systematic Assessment	EG00028 affected209 at risk EG00123 affected203 at risk
Alanine aminotransferase increased	Investigations	MedDRA Ver. 19.0	Systematic Assessment	EG0006 affected209 at risk EG0012 affected203 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Ver. 19.0	Systematic Assessment	EG0005 affected209 at risk EG0011 affected203 at risk
Weight increased	Investigations	MedDRA Ver. 19.0	Systematic Assessment	EG0009 affected209 at risk EG0011 affected203 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0001 affected209 at risk EG0014 affected203 at risk
Muscle rigidity	Musculoskeletal and connective tissue disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0000 affected209 at risk EG0015 affected203 at risk
Akathisia	Nervous system disorders	MedDRA Ver. 19.0	Systematic Assessment	EG00027 affected209 at risk EG0017 affected203 at risk
Dizziness	Nervous system disorders	MedDRA Ver. 19.0	Systematic Assessment	EG00010 affected209 at risk EG00110 affected203 at risk
Headache	Nervous system disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0008 affected209 at risk EG00113 affected203 at risk
Somnolence	Nervous system disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0005 affected209 at risk EG0015 affected203 at risk
Tremor	Nervous system disorders	MedDRA Ver. 19.0	Systematic Assessment	EG00012 affected209 at risk EG00111 affected203 at risk
Insomnia	Psychiatric disorders	MedDRA Ver. 19.0	Systematic Assessment	EG0009 affected209 at risk EG0015 affected203 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Everton Park	Queensland		Australia

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Gastric ulcer	Gastrointestinal disorders	MedDRA Ver. 19.0	Systematic Assessment		EG0000 events0 affected209 at risk EG0011 events1 affected203 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA Ver. 19.0	Systematic Assessment		EG0000 events0 affected209 at risk EG0011 events1 affected203 at risk