Age | Outpatients | Informed Consent | parent | Health Insurance Portability and Accountability Act
Item
1. male or female outpatients aged ≥7 to <18 years (at screening visit 1). 2. provide assent (subject) and written informed consent (parent/legal representative) and health insurance portability and accountability act (hipaa) for study participation (at screening visit 1).
boolean
C0001779 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0030551 (UMLS CUI [4])
C0600593 (UMLS CUI [5])
Major Depressive Disorder Diagnostic Criteria Met DSM-IV
Item
3. meet diagnostic criteria for mdd as defined in the dsm iv-tr5 at screening visits 1 and 1a (k-sads-pl; see appendix 17.2).
boolean
C1269683 (UMLS CUI [1,1])
C3897171 (UMLS CUI [1,2])
C0220952 (UMLS CUI [1,3])
Depressive episode Duration
Item
4. current depressive episode of at least 4 weeks' duration as noted in the subject's history (screening visit 1).
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Depression in children Rating scale Score
Item
5. total cdrs-r raw score ≥45 at both the screening and baseline visits (visits 1 and 2) (see appendix 17.3).
boolean
C3826462 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Clinical Global Impression Questionnaire
Item
6. cgi-s score of ≥4 at the baseline visit (visit 2) (see appendix 17.4).
boolean
C3639708 (UMLS CUI [1])
Inability to swallow oral medication | Difficulty
Item
are unable to swallow medications without difficulty
boolean
C0221470 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0332218 (UMLS CUI [2])
Hypersensitivity Bupropion hydrobromide
Item
• have known hypersensitivity to bupropion hydrobromide
boolean
C0020517 (UMLS CUI [1,1])
C2316497 (UMLS CUI [1,2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
are pregnant or planning to get pregnant or are lactating
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Childbearing Potential Age | Contraceptive methods Unable
Item
women of childbearing age unable to use at least one method of effective contraception for the duration of the study
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Previous known suicide attempt | Unable to communicate Parent Clinical Investigators Study Coordinator
Item
previous history of attempted suicide are unable to understand and communicate effectively with parent, investigator, and study coordinator
boolean
C0277666 (UMLS CUI [1])
C0566000 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0008961 (UMLS CUI [2,3])
C1710220 (UMLS CUI [2,4])
Hospitalization Requirement At risk
Item
are at immediate risk of requiring hospitalization, in the investigator's opinion
boolean
C0019993 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Epilepsy | Seizures | Craniocerebral Trauma
Item
have current seizure disorder or history of seizures or head trauma
boolean
C0014544 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0018674 (UMLS CUI [3])
medical condition Clinical Significance | LABORATORY ABNORMALITIES
Item
have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities
boolean
C1699700 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1853129 (UMLS CUI [2])
ECG abnormality | Physical Examination Abnormal Finding
Item
have ecg or physical examination abnormality at screening
boolean
C0522055 (UMLS CUI [1])
C2826636 (UMLS CUI [2])
Body Weight | weight percentile for age
Item
have body weight less than the 3rd percentile or greater than the 97th percentile for age.
boolean
C0005910 (UMLS CUI [1])
C0517416 (UMLS CUI [2])