Severe depression | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
currently have severe depression (major depressive disorder - without psychotic features)
boolean
C0588008 (UMLS CUI [1])
C0743081 (UMLS CUI [2])
Major depressive episode Duration
Item
meet criteria (dsm iv-tr ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
depression questionnaire (hamd17) total score greater than or equal to 24
boolean
C3639712 (UMLS CUI [1])
Informed Consent
Item
subject must read and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female 18 to 64 years
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods Appropriate
Item
use appropriate birth control method
boolean
C0700589 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
Body mass index
Item
bmi 18.8 - 35.0 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Principal diagnosis Mental disorders Other
Item
primary diagnosis of other psychiatric disorders
boolean
C0332137 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Feeling suicidal | Homicidal thoughts
Item
thoughts of killing ones self or someone else
boolean
C0424000 (UMLS CUI [1])
C0455204 (UMLS CUI [2])
Psychiatric drugs | Psychiatric therapeutic procedure
Item
taking psychiatric medicine or therapy within the six months
boolean
C1979799 (UMLS CUI [1])
C0204523 (UMLS CUI [2])
Major Depressive Disorder | Pharmaceutical Preparations Course failed | Antidepressive Agents Class Different Quantity
Item
has previously failed an adequate course of medication for mdd from two different classes of antidepressants.
boolean
C1269683 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0003289 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Disease Unstable | Disease Interferes with Drug effect
Item
unstable medical disorder or a disorder that would interfere with the action of the drug
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0728866 (UMLS CUI [2,3])
Substance Use Disorders
Item
abuse of alcohol or drugs
boolean
C0038586 (UMLS CUI [1])
Serotonin Syndrome | Intolerance to SSRIs
Item
past history of serotonin syndrome or a history of clinical significant intolerance of ssris (class of drugs used for depression).
boolean
C0699828 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0360105 (UMLS CUI [2,2])
Migraine Disorders Response Triptans
Item
history of migraine headaches that respond to treatment with triptan medication.
boolean
C0149931 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C1567966 (UMLS CUI [1,3])
Abnormal nervous system function | Dementia | Cognition Disorders | Craniocerebral Trauma | Seizure Except Febrile seizure
Item
history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
boolean
C0234072 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0009241 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
C0036572 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C0009952 (UMLS CUI [5,3])
Study Subject Participation Status
Item
currently taking part in another clinical study or has done so within six months
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, planning to become pregnant shortly or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Drug Allergy | Hypersensitivity
Item
history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4])