Age | Major Depressive Disorder | Quick Inventory of Depressive Symptomatology Self-Report Version Questionnaire
Item
subjects will be male and female subjects between the ages of 18 to 65 meeting the diagnostic and statistical manual of mental disorders-iv-text revision (dsm-iv-tr) criteria for major depressive disorder with a quick inventory of depressive symptomatology-16 item self report (qids-sr16) score of >14 at the screening and baseline visits.
boolean
C0001779 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C4331197 (UMLS CUI [3])
Gender Contraceptive methods Stable | Gender Urine pregnancy test negative
Item
female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the screening visit.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Axis I diagnosis Other Primary | Obsessive-Compulsive Disorder | Psychotic Disorders | Bipolar Disorder | Mental Retardation
Item
subjects with any other psychiatric axis-i disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study.
boolean
C0270287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332137 (UMLS CUI [1,3])
C0028768 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0025362 (UMLS CUI [5])
At risk for suicide | Eating Disorders | Substance Dependence | Substance Use Disorders
Item
subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible.
boolean
C0563664 (UMLS CUI [1])
C0013473 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
Abnormality Clinical Significance Screening | Abnormality Clinical Significance Baseline Assessment | Laboratory test result abnormal
Item
subjects with clinically significant abnormalities on any screening or baseline assessments, including laboratory tests, are excluded.
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1442488 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
C0438215 (UMLS CUI [3])
Intolerance to Buspirone | Intolerance to Melatonin | Medical condition Clinical Significance compromises Study Subject Participation Status | Mental condition Clinical Significance compromises Study Subject Participation Status
Item
subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study.
boolean
C1744706 (UMLS CUI [1,1])
C0006462 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0025219 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3840291 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Selective Serotonin Reuptake Inhibitors | Fluoxetine | Patient need for Antipsychotic Agents | Patient need for Anti-Anxiety Agents | Patient need for Psychotropic Drugs
Item
subjects who have used selective serotonin reuptake inhibitors (ssris) within 2 weeks of screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.
boolean
C0360105 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0040615 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C0040616 (UMLS CUI [4,2])
C0686904 (UMLS CUI [5,1])
C0033978 (UMLS CUI [5,2])