Outpatients | Age
Item
1. male or female outpatients;12-17 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder
Item
2. meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd) , confirmed by kiddie schedule for affective disorders and schizophrenia for school-age children--present and lifetime (k-sads-pl)
boolean
C1269683 (UMLS CUI [1])
Depression in children Rating scale
Item
3. score ≥ 40 on the children's depression rating scale-revised (cdrs-r) at visits 1 and 2
boolean
C3826462 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
CGI - Severity of Illness
Item
4. clinical global impressions-severity (cgi-s) score ≥ 4 at visits 1 and 2
boolean
C3639887 (UMLS CUI [1])
Caregiver reliable
Item
5. reliable caregiver
boolean
C0085537 (UMLS CUI [1,1])
C3858758 (UMLS CUI [1,2])
Physical examination normal | Normal vital signs | Laboratory test normal | ECG normal
Item
6. physical examination, vital signs, clinical laboratory tests, and ecg normal or not clinically significant
boolean
C0855737 (UMLS CUI [1])
C0277803 (UMLS CUI [2])
C1096215 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
Exclusion Criteria Psychiatric Main
Item
key psychiatric exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Primary therapy Axis I diagnosis | Exception Major Depressive Disorder
Item
1. dsm-iv-tr-based diagnosis of an axis i disorder other than mdd that is the primary focus of treatment
boolean
C1708063 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Mental Retardation | Amnestic Disorder | Cognition Disorders
Item
2. mental retardation or amnestic or other cognitive disorders
boolean
C0025362 (UMLS CUI [1])
C0002625 (UMLS CUI [2])
C0009241 (UMLS CUI [3])
At risk for suicide
Item
3) significant suicide risk:
boolean
C0563664 (UMLS CUI [1])
Suicide attempt
Item
suicide attempt within the past year or
boolean
C0038663 (UMLS CUI [1])
Investigator Judgment Columbia suicide severity rating scale
Item
investigator judgment (based on psychiatric interview and c-ssrs)
boolean
C0035173 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C3888485 (UMLS CUI [1,3])
Exclusion Criteria Main Relationship Treatment
Item
key treatment-related exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Hypersensitivity Levomilnacipran | Intolerance to Levomilnacipran | Hypersensitivity Milnacipran | Intolerance to Milnacipran | Fluoxetine allergy | Intolerance to Fluoxetine | Selective serotonin re-uptake inhibitor allergy | Intolerance to Selective Serotonin Reuptake Inhibitors | Hypersensitivity Serotonin and Norepinephrine Reuptake Inhibitor | Intolerance to Serotonin and Norepinephrine Reuptake Inhibitor
Item
1. allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitors (snri)
boolean
C0020517 (UMLS CUI [1,1])
C3541367 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C3541367 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1533126 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C1533126 (UMLS CUI [4,2])
C0570770 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0016365 (UMLS CUI [6,2])
C0570765 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C0360105 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C3537213 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C3537213 (UMLS CUI [10,2])
Illicit medication use | Illicit medication use Discontinue Unsuccessful
Item
2. use of prohibited concomitant medication that cannot be discontinued
boolean
C0281875 (UMLS CUI [1])
C0281875 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Exclusion Criteria Medical Main
Item
other key medical exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Medical condition Interferes with Completion of clinical trial | Medical condition Interferes with Interpretation Research results | Medical condition Affecting Patient safety
Item
1. any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
Liver enzyme test | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
2. liver enzyme tests (aspartate aminotransferase) ast and/or alanine aminotransferase (alt) > 2x the upper limit of normal (uln)
boolean
C0428321 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Cardiovascular Disease
Item
3. clinically significant cardiovascular disorders
boolean
C0007222 (UMLS CUI [1])
Epilepsy | At risk Epilepsy
Item
4. seizure disorder or risk of seizure
boolean
C0014544 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
5. drug or alcohol abuse or dependence (within the past year)
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Urine drug screen positive | Blood alcohol test positive
Item
6. positive urine drug screen or blood alcohol
boolean
C0743300 (UMLS CUI [1])
C0948726 (UMLS CUI [2])