Major Depressive Disorder
Conditions
Interventions
investigational material(s)
Generic name etc : ASC-01 (Aripiprazole/Sertraline Combination)
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administr
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are either inpatients or outpatients. 2) 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. 3)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 4) Patients with a HAM-D17 total score of 18 or more at the Screening Period evaluation
Exclusion criteria
Exclusion criteria: 1) 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 2) Pregnant or breast-feeding female patients, or female patients who may be pregnant 3) Patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history 4) Patients who have had electroconvulsive therapy 5) Patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent 6) 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) 7) Patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic i) fasting blood glucose level equal to or more than 126 mg/dL, ii) 2-hour glucose level in 75-g oral glucose tolerance test (OGTT) equal to or more than 200 mg/dL, iii) non-fasting blood glucose level equal to or more than 200 mg/dL, or iv) HbA1c [NGSP level] equal to or more than 6.5%) 8) 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) 9) Patients who have a history of neuroleptic malignant syndrome or serotonin syndrome 10) Patients who have a history of seizure disorder (eg, epilepsy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Montgomery-Asberg Depression Rating Scale (MADRS) 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Clinical Global Impression-Global Improvement (CGI-I) 14 weeks efficacy Clinical Global Impression-Severity of illness (CGI-S) 14 weeks efficacy Hamilton Depression Rating Scale (HAM-D) 14 weeks | — |
Countries
Asia except Japan, Japan, Oceania
Outcome results
None listed