Age
Item
female and male subjects must be 18 to 65 years of age;
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
have body mass index (bmi) greater or equal to 27 and less than or to equal 43kg/m2;
boolean
C1305855 (UMLS CUI [1])
Major Depressive Disorder
Item
meet criteria for major depression
boolean
C1269683 (UMLS CUI [1])
Childbearing Potential Breast Feeding Absent | Childbearing Potential Contraceptive methods
Item
women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
boolean
C3831118 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Protocol Compliance
Item
able to comply with all required study procedures and schedule;
boolean
C0525058 (UMLS CUI [1])
Able to speak English Language | Able to read English Language
Item
able to speak and read english;
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Informed Consent
Item
willing and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Obesity of endocrine origin
Item
obesity of known endocrine origin
boolean
C0267992 (UMLS CUI [1])
Medical condition Serious
Item
serious medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence
Item
history of drug or alcohol abuse or dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Pharmaceutical Preparations Excluded
Item
use of excluded concomitant medications
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Obesity surgery | Medical Device Intervention Obesity | Gastric band Intervention Obesity
Item
history of surgical or device (e.g. gastric banding) intervention for obesity;
boolean
C1167841 (UMLS CUI [1])
C0025080 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
C3854330 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0028754 (UMLS CUI [3,3])
Seizures | Predisposition Seizures
Item
history or predisposition to seizures
boolean
C0036572 (UMLS CUI [1])
C0220898 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Operative Surgical Procedure Planned | Impact Clinical Trial
Item
planned surgical procedure that can impact the conduct of the study;
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C4049986 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Investigational New Drugs | Investigational Medical Device | Procedure Investigational
Item
use of investigational drug, device or procedure within 30 days prior to screening;
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
Study Subject Participation Status
Item
participation in any previous clinical trial conducted by orexigen therapeutics;
boolean
C2348568 (UMLS CUI [1])
Condition Study Subject Participation Status Inappropriate
Item
any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])