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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.

Tracking Information
First Submitted Date  ICMJE January 23, 2014
First Posted Date  ICMJE January 28, 2014
Results First Submitted Date  ICMJE August 16, 2017
Results First Posted Date  ICMJE May 21, 2018
Last Update Posted Date May 21, 2018
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2014)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, 14 weeks ]
Change History Complete list of historical versions of study NCT02046564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2014)
Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, 14 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Official Title  ICMJE A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: ASC-01
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: ASC-01
    The dose of 3-12mg/100mg(Aripiprazole/Sertraline Combination)will be orally administered once daily
    Intervention: Drug: ASC-01
  • Placebo Comparator: Placebo
    The dose of 0mg/100mg (Placebo/Sertraline Combination )will be orally administered once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2017)
412
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2014)
400
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Japan,   Korea, Republic of,   Malaysia,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02046564
Other Study ID Numbers  ICMJE 031-12-005
JapicCTI-142413 ( Other Identifier: Japic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP