Inpatient | Outpatients
Item
patients who are either inpatients or outpatients.
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Protocol Compliance | Informed Consent
Item
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.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Major depression, single episode | Major Depressive Disorder Recurrent | Major depressive episode Duration
Item
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
boolean
C0024517 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0024517 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
patients with a ham-d 17 total score of 18 or more at the screening period evaluation
boolean
C3639712 (UMLS CUI [1])
Childbearing Potential Planned Pregnancy
Item
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
boolean
C3831118 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Possible pregnancy
Item
pregnant or breast-feeding female patients, or female patients who may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
Intolerance to Antidepressive Agents
Item
patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
boolean
C1744706 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
Electroconvulsive Therapy
Item
patients who have had electroconvulsive therapy
boolean
C0013806 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Adverse event Interferes with Evaluation | Symptoms Interfere with Evaluation | Symptoms Fibromyalgia | Symptoms Premenstrual syndrome | Interference Depressive Symptoms
Item
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)
boolean
C0877248 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0016053 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C0033046 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C0086132 (UMLS CUI [5,2])
Complications of Diabetes Mellitus | Diabetes Mellitus | Diabetic
Item
patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic
boolean
C0342257 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0241863 (UMLS CUI [3])
Fasting blood glucose measurement
Item
fasting blood glucose level ≥ 126 mg/dl
boolean
C0428568 (UMLS CUI [1])
Glucose measurement | Oral Glucose Tolerance Test
Item
2-hour glucose level in 75-g oral glucose tolerance test (ogtt) ≥ 200 mg/dl
boolean
C0337438 (UMLS CUI [1])
C0029161 (UMLS CUI [2])
Blood glucose measurement
Item
non-fasting blood glucose level ≥ 200 mg/dl
boolean
C0392201 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c [ngsp level] ≥ 6.5%
boolean
C0474680 (UMLS CUI [1])
Treatment Thyroid Disease
Item
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)
boolean
C0087111 (UMLS CUI [1,1])
C0040128 (UMLS CUI [1,2])
Neuroleptic Malignant Syndrome | Serotonin Syndrome
Item
patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
boolean
C0027849 (UMLS CUI [1])
C0699828 (UMLS CUI [2])
Epilepsy
Item
patients who have a history of seizure disorder (eg, epilepsy)
boolean
C0014544 (UMLS CUI [1])