Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
Scientific title
A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Query!
Secondary ID [1]
0
0
JapicCTI-142413
Query!
Secondary ID [2]
0
0
031-12-005
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Depression
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
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
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Query!
Assessment method [1]
0
0
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.
Query!
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])
Query!
Secondary outcome [1]
0
0
The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
Query!
Assessment method [1]
0
0
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.
Query!
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])
Query!
Secondary outcome [2]
0
0
The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
Query!
Assessment method [2]
0
0
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.
Query!
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])
Query!
Secondary outcome [3]
0
0
The Clinical Global Impression - Improvement (CGI-I) Improvement Rate
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])
Query!
Secondary outcome [4]
0
0
The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)
Query!
Assessment method [4]
0
0
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.
Query!
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])
Query!
Secondary outcome [5]
0
0
The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score
Query!
Assessment method [5]
0
0
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.
Query!
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])
Query!
Secondary outcome [6]
0
0
The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score
Query!
Assessment method [6]
0
0
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.
Query!
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])
Query!
Secondary outcome [7]
0
0
The Mean Change From Baseline in the Apathy Scale (AS) Total Score
Query!
Assessment method [7]
0
0
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.
Query!
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])
Query!
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
Query!
Assessment method [8]
0
0
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.
Query!
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])
Query!
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
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
64
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
412
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
- Everton Park
Query!
Recruitment hospital [2]
0
0
- Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Everton Park
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Japan
Query!
State/province [1]
0
0
Chubu Region
Query!
Country [2]
0
0
Japan
Query!
State/province [2]
0
0
Chugoku Region
Query!
Country [3]
0
0
Japan
Query!
State/province [3]
0
0
Hokkaido Region
Query!
Country [4]
0
0
Japan
Query!
State/province [4]
0
0
Kanto Region
Query!
Country [5]
0
0
Japan
Query!
State/province [5]
0
0
Kinki Region
Query!
Country [6]
0
0
Japan
Query!
State/province [6]
0
0
Kyushu Region
Query!
Country [7]
0
0
Japan
Query!
State/province [7]
0
0
Tohoku Region
Query!
Country [8]
0
0
Korea, Republic of
Query!
State/province [8]
0
0
Busan
Query!
Country [9]
0
0
Korea, Republic of
Query!
State/province [9]
0
0
Chungcheongnam-do
Query!
Country [10]
0
0
Korea, Republic of
Query!
State/province [10]
0
0
Deagu
Query!
Country [11]
0
0
Korea, Republic of
Query!
State/province [11]
0
0
Gangwon-do
Query!
Country [12]
0
0
Korea, Republic of
Query!
State/province [12]
0
0
Gwangju
Query!
Country [13]
0
0
Korea, Republic of
Query!
State/province [13]
0
0
Gyeonggi-do
Query!
Country [14]
0
0
Korea, Republic of
Query!
State/province [14]
0
0
Incheon
Query!
Country [15]
0
0
Korea, Republic of
Query!
State/province [15]
0
0
Jeollabuk-do
Query!
Country [16]
0
0
Korea, Republic of
Query!
State/province [16]
0
0
Seoul
Query!
Country [17]
0
0
Malaysia
Query!
State/province [17]
0
0
Ipoh
Query!
Country [18]
0
0
Malaysia
Query!
State/province [18]
0
0
Johor Bahru
Query!
Country [19]
0
0
Malaysia
Query!
State/province [19]
0
0
Kuala Lumpur
Query!
Country [20]
0
0
Malaysia
Query!
State/province [20]
0
0
Kuching
Query!
Country [21]
0
0
Taiwan
Query!
State/province [21]
0
0
Chiayi
Query!
Country [22]
0
0
Taiwan
Query!
State/province [22]
0
0
Kaohsiung
Query!
Country [23]
0
0
Taiwan
Query!
State/province [23]
0
0
Keelung
Query!
Country [24]
0
0
Taiwan
Query!
State/province [24]
0
0
Taichung
Query!
Country [25]
0
0
Taiwan
Query!
State/province [25]
0
0
Tainan
Query!
Country [26]
0
0
Taiwan
Query!
State/province [26]
0
0
Taipei
Query!
Country [27]
0
0
Taiwan
Query!
State/province [27]
0
0
Taoyuan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Otsuka Pharmaceutical Co., Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02046564
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Hiroaki Ono, Mr
Query!
Address
0
0
Otsuka Pharmaceutical Co., Ltd.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02046564
Download to PDF