Outpatients | Age
Item
1. outpatients aged 20-65 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
2. subjects must be able to understand and willing to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
3. female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
4. met criteria for mdd without psychotic features as defined by the diagnostic and statistical manual of mental disorders, fourth edition text revision® (dsm-iv-tr) and confirmed by use of the mini international neuropsychiatric interview (mini).
boolean
C0743081 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Clinical global impression scale
Item
5. 17-item ham-d (hamilton rating scale for depression) total score ≧20 and cgi (clinical global impression) total score ≧4
boolean
C3639712 (UMLS CUI [1])
C3639708 (UMLS CUI [2])
Mental disorders Major compromise Clinical Trial | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Bipolar I disorder | Bipolar II disorder | Manic episode | Hypomanic episode | Schizophrenia | Axis II diagnosis Major | Major depression with psychotic features | Mental Retardation
Item
1. have a current or previous major psychiatric disorders which be defined to be per the dsm-iv-tr, including obsessive-compulsive disorder, posttraumatic stress disorder, bipolar i or ii, manic or hypomanic episode, schizophrenia, major axis ii disorders which might compromise the study, and major depression with psychotic symptoms, mental retardation.
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0028768 (UMLS CUI [2])
C0038436 (UMLS CUI [3])
C0853193 (UMLS CUI [4])
C0236788 (UMLS CUI [5])
C0349208 (UMLS CUI [6])
C1396834 (UMLS CUI [7])
C0036341 (UMLS CUI [8])
C0270288 (UMLS CUI [9,1])
C0205164 (UMLS CUI [9,2])
C4518519 (UMLS CUI [10])
C0025362 (UMLS CUI [11])
Therapeutic procedure Major Depressive Disorder | Fluoxetine
Item
2. use of any treatment for mdd in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
boolean
C0087111 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C0016365 (UMLS CUI [2])
Psychotropic Drugs | Exception Relationship Insomnia
Item
3. use of psychoactive drugs within the last 2 weeks before visit 1 other than that subjects had insomnia who need the treatment as determined by the investigator.
boolean
C0033978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0917801 (UMLS CUI [2,3])
Therapy non-responder | Antidepressant therapy Quantity | Antidepressive Agents Dose Symptom control (therapy) | Depressive Disorder, Treatment-Resistant | Electroconvulsive Therapy | Transcranial magnetic stimulation | Psychosurgery
Item
4. subjects who were non-responsive to two or more courses of antidepressant medications given an adequate dosage for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (trd), or a history of electroconvulsive therapy (ect), transcranial magnetic stimulation (tms) or psychosurgery within the last year.
boolean
C0919875 (UMLS CUI [1])
C1096649 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1274136 (UMLS CUI [3,3])
C2063866 (UMLS CUI [4])
C0013806 (UMLS CUI [5])
C0436548 (UMLS CUI [6])
C0033967 (UMLS CUI [7])
Epilepsy
Item
5. have a history of any seizure disorder.
boolean
C0014544 (UMLS CUI [1])
Abnormal vital signs Interfere with Clinical Trial | Electrocardiogram abnormal Interferes with Clinical Trial | Laboratory test result abnormal Interferes with Clinical Trial
Item
6. any clinically significant abnormal vital sign, ecg, laboratory values as determined by the investigator which might interfere with the study.
boolean
C0277804 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
Organic disease caused by Depression | Organic disease Poorly controlled | Nervous system disorder | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Endocrine System Diseases | Hematological Disease | Disease Major
Item
7. any organic disorder caused u medical related depression which cannot be under well-controlled such as clinically significant in neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders
boolean
C0683324 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
C0683324 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
C0012634 (UMLS CUI [12,1])
C0205164 (UMLS CUI [12,2])
High suicide risk
Item
8. have a high suicidal risk as measured by mini.
boolean
C1271074 (UMLS CUI [1])
Substance Use Disorders | Urine drug screen positive
Item
9. have a history of substance abuse within the past 6 months or a positive urine drug screen for any substance of abuse at visit 1.
boolean
C0038586 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
Drug Allergy Severe | Pharmaceutical Preparations Class Quantity | Adverse reaction to drug multiple
Item
10. have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0041755 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])