Age
Item
1. males or females between 18 and 65 years of age (inclusive).
boolean
C0001779 (UMLS CUI [1])
Outpatients | Inpatients | Major Depressive Disorder
Item
2. either outpatients or inpatients diagnosed with major depressive disorder (mdd) according to diagnostic and statistical manual of mental disorders (dsm-iv-tr, see appendix 3) and mini international neuropsychiatric interview (mini).
boolean
C0029921 (UMLS CUI [1])
C0021562 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
Depressive episode Recurrent Duration | Response Antidepressant therapy Quantity
Item
3. patients with recurrent depressive episode of at least 2 months in duration. patients must have previously responded (significant clinical improvement judged by the principal investigator) to at least one antidepressant treatment.
boolean
C0349217 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C1096649 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Run-in Placebo Hamilton Depression Rating Scale 17 Item Clinical Classification | Baseline state Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
4. hamd-17 total score * 22 with a severity score of at least 2 on item 1 at the placebo run-in visit and the baseline/day 1 visit.
boolean
C3639712 (UMLS CUI [1])
C3274438 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
C3639712 (UMLS CUI [2,3])
C1290922 (UMLS CUI [3,1])
C3639712 (UMLS CUI [3,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification Reduction Percentage | Difference Run-in Placebo Baseline state
Item
5. hamd-17 score reduction ≤ 15% between the placebo run-in visit and the baseline/day 1 visit.
boolean
C3639712 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1705242 (UMLS CUI [2,1])
C3274438 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
C1290922 (UMLS CUI [2,4])
Hamilton Anxiety Rating Scale Questionnaire
Item
6. ham-a total score < 17 at the screening visit.
boolean
C3541258 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification Reduction Percentage | Difference Run-in Placebo Baseline state | Placebo Responder
Item
1. patients with a hamd-17 total score reduction of more than 15% between the placebo run-in visit and the baseline/day 1 visit (placebo responders).
boolean
C3639712 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1705242 (UMLS CUI [2,1])
C3274438 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
C1290922 (UMLS CUI [2,4])
C0032042 (UMLS CUI [3,1])
C0919876 (UMLS CUI [3,2])
Major Depressive Disorder Unresponsive to Treatment | Monoamine Oxidase Inhibitors
Item
2. patients with a medical history of mdd that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (mao) inhibitor.
boolean
C1269683 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0026457 (UMLS CUI [2])
Antidepressant therapy Resistant | Antidepressant therapy failed | Class pharmacological different Quantity | Tricyclic Antidepressant | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | Monoamine Oxidase Inhibitors
Item
3. patients who are known to be antidepressant treatment-resistant. patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., tca, ssri, snri, mao-i, etc). failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the principal investigator's discretion.
boolean
C1096649 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C1096649 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0456387 (UMLS CUI [3,1])
C0205464 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C3536819 (UMLS CUI [4])
C0360105 (UMLS CUI [5])
C1579361 (UMLS CUI [6])
C0026457 (UMLS CUI [7])
Major Depressive Disorder Unresponsive to Electroconvulsive Therapy | Electroconvulsive Therapy Previous
Item
4. patients with a medical history of mdd who consistently did not respond significantly to electroconvulsive shock therapy (ect) or had ect within a year prior to the screening visit regardless of outcome.
boolean
C1269683 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0013806 (UMLS CUI [1,3])
C0013806 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Depression, psychotic
Item
5. patients with psychotic depression
boolean
C0743072 (UMLS CUI [1])