Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ASC-01; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 412.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

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.
    

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)