Major depressive disorder with melancholic features
Item
have a diagnosis of major depression with melancholic features, as defined by diagnostic and statistical manual of mental disorders fourth edition [dsm-iv] criteria.
boolean
C1096724 (UMLS CUI [1])
Single major depressive episode First | Age
Item
experienced their first episode of major depression prior to age 50.
boolean
C0024517 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Hamilton rating scale for depression
Item
have a hamd17 total score of less than or equal to 20 at visits 1 and 2.
boolean
C0451203 (UMLS CUI [1])
Gender Urine pregnancy test negative
Item
test negative for a urine pregnancy test at visit 1 (females).
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Female Sterilization | Menarche between | Postmenopausal state
Item
agree to use medically acceptable and reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential, not surgically sterilized and between menarche, and one year post-menopausal).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0025274 (UMLS CUI [3,1])
C0205103 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
Axis I diagnosis Mood Disorder Primary | Major Depressive Disorder | Dysthymic Disorder | Seasonal Affective Disorder | Depression, psychotic
Item
have any current and primary axis i mood disorder other than mdd, including, but not limited to, dysthymia, seasonal affective disorder or psychotic depression.
boolean
C0270287 (UMLS CUI [1,1])
C0525045 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1269683 (UMLS CUI [2])
C0013415 (UMLS CUI [3])
C0085159 (UMLS CUI [4])
C0743072 (UMLS CUI [5])
Single major depressive episode | Antidepressive Agents Course Quantity Unresponsive to Treatment | Depressive Disorder, Treatment-Resistant
Item
have a current episode of major depression that has failed to respond to two or more courses of antidepressant therapy or, in the judgment of the investigator, meets criteria for treatment-resistant depression
boolean
C0024517 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205269 (UMLS CUI [2,4])
C2063866 (UMLS CUI [3])
At risk for suicide Serious
Item
are at serious suicidal risk as determined by the investigator.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Illness Serious Requirement Pharmaceutical Preparations | LABORATORY ABNORMALITIES Clinical Significance Requirement Pharmaceutical Preparations
Item
have a serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Surgical and medical procedures | Hospitalization
Item
intervention/ hospitalization during the course of the study.
boolean
C1948041 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Monoamine Oxidase Inhibitors | Investigational New Drug Discontinuation
Item
had treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to visit 2 or potential need to use a maoi during the study or within 14 days of discontinuation of study drug.
boolean
C0026457 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])