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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02046564




Registration number
NCT02046564
Ethics application status
Date submitted
23/01/2014
Date registered
28/01/2014
Date last updated
21/05/2018

Titles & IDs
Public title
Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Scientific title
A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Secondary ID [1] 0 0
JapicCTI-142413
Secondary ID [2] 0 0
031-12-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASC-01
Treatment: Drugs - Placebo

Experimental: ASC-01 - The dose of 3-12mg/100mg(Aripiprazole/Sertraline Combination)will be orally administered once daily

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


Treatment: Drugs: ASC-01


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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 [1] 0 0
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.
Timepoint [1] 0 0
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 [2] 0 0
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.
Timepoint [2] 0 0
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 [3] 0 0
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.
Timepoint [3] 0 0
6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
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 [5] 0 0
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.
Timepoint [5] 0 0
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 [6] 0 0
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.
Timepoint [6] 0 0
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 [7] 0 0
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.
Timepoint [7] 0 0
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 [8] 0 0
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.
Timepoint [8] 0 0
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])

Eligibility
Key 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
Minimum age
20 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Everton Park
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Everton Park
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Chubu Region
Country [2] 0 0
Japan
State/province [2] 0 0
Chugoku Region
Country [3] 0 0
Japan
State/province [3] 0 0
Hokkaido Region
Country [4] 0 0
Japan
State/province [4] 0 0
Kanto Region
Country [5] 0 0
Japan
State/province [5] 0 0
Kinki Region
Country [6] 0 0
Japan
State/province [6] 0 0
Kyushu Region
Country [7] 0 0
Japan
State/province [7] 0 0
Tohoku Region
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Busan
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Chungcheongnam-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Deagu
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Gangwon-do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Gwangju
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Gyeonggi-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Incheon
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Jeollabuk-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Malaysia
State/province [17] 0 0
Ipoh
Country [18] 0 0
Malaysia
State/province [18] 0 0
Johor Bahru
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kuala Lumpur
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuching
Country [21] 0 0
Taiwan
State/province [21] 0 0
Chiayi
Country [22] 0 0
Taiwan
State/province [22] 0 0
Kaohsiung
Country [23] 0 0
Taiwan
State/province [23] 0 0
Keelung
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taichung
Country [25] 0 0
Taiwan
State/province [25] 0 0
Tainan
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Otsuka Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02046564
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hiroaki Ono, Mr
Address 0 0
Otsuka Pharmaceutical Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications