Age
Item
male or female between the ages of 18 and 65 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of mdd according to the diagnostic and statistical manual of mental disorders (dsm)-iv criteria and a shortened mini evaluation
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire | Depressed mood Hamilton Depression Rating Scale 17 Item Questionnaire
Item
ham-d17 score of >/= 21 and a severity score of at least 2 for item 1 (depressed mood) at both screening and baseline
boolean
C3639712 (UMLS CUI [1])
C0344315 (UMLS CUI [2,1])
C3639712 (UMLS CUI [2,2])
Depressive episode Duration | Depressed mood | Anhedonia
Item
current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to screening.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0344315 (UMLS CUI [2])
C0178417 (UMLS CUI [3])
Fluoxetine | Antidepressive Agents | Pharmaceutical Preparations Without License
Item
subjects who have received fluoxetine within 1 month prior to baseline or any other antidepressant within 2 weeks prior to baseline, or any unlicensed medication within 1 month before screening
boolean
C0016365 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0023636 (UMLS CUI [3,3])
Patient need for Psychotropic Drugs | Exception Investigational New Drugs
Item
subjects who require psychotropic medication other than the study medication
boolean
C0686904 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Psychotherapy Started
Item
subjects who started psychotherapy within 4 months prior to screening
boolean
C0033968 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
Syndrome Bipolar | Depression, psychotic | Somatoform Disorder Severe | Eating Disorder Severe
Item
subjects who currently (i.e., in the month prior to screening) meet dsm-iv criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
boolean
C0039082 (UMLS CUI [1,1])
C0443156 (UMLS CUI [1,2])
C0743072 (UMLS CUI [2])
C0037650 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0013473 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Principal diagnosis Anxiety
Item
subjects who have a primary diagnosis of anxiety
boolean
C0332137 (UMLS CUI [1,1])
C0003467 (UMLS CUI [1,2])
Sleeping pills Regular Frequency
Item
subjects who regularly use sleeping medication more than 3 times per week
boolean
C0599396 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Mental disorders Severe | Nervous system disorder Severe | Exception Major Depressive Disorder
Item
subjects who have major psychiatric or neurologic disorders other than mdd
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1269683 (UMLS CUI [3,2])
Depressive disorder Secondary to Cerebrovascular accident | Depressive disorder Secondary to Malignant Neoplasms | Depressive disorder Secondary to Severe disorder
Item
subjects with depression secondary to stroke, cancer, or other severe medical illness
boolean
C0011581 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0011581 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C1836348 (UMLS CUI [3,3])
Substance Dependence
Item
subjects who have a history of alcohol or substance dependence(within 1 year prior to screening)
boolean
C0038580 (UMLS CUI [1])