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

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ClinicalTrials.gov Identifier: NCT02046564
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ASC-01 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Actual Study Start Date : February 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [ 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]) ]
    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 :
  1. The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate [ 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]) ]

    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.


  2. The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate [ 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]) ]

    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.


  3. The Clinical Global Impression - Improvement (CGI-I) Improvement Rate [ Time Frame: 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF]) ]
    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.

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

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

    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.


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

  7. The Mean Change From Baseline in the Apathy Scale (AS) Total Score [ 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]) ]
    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.

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



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046564


Locations
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Australia, Queensland
Everton Park, Queensland, Australia
Australia
Melbourne, Australia
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Tohoku Region, Japan
Korea, Republic of
Busan, Korea, Republic of
Chungcheongnam-do, Korea, Republic of
Deagu, Korea, Republic of
Gangwon-do, Korea, Republic of
Gwangju, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Incheon, Korea, Republic of
Jeollabuk-do, Korea, Republic of
Seoul, Korea, Republic of
Malaysia
Ipoh, Malaysia
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Kuching, Malaysia
Taiwan
Chiayi, Taiwan
Kaohsiung, Taiwan
Keelung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02046564     History of Changes
Other Study ID Numbers: 031-12-005
JapicCTI-142413 ( Other Identifier: Japic )
First Posted: January 28, 2014    Key Record Dates
Results First Posted: May 21, 2018
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms