ID

28837

Beschreibung

A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00624858

Link

https://clinicaltrials.gov/show/NCT00624858

Stichworte

Versionen (1)
  1. 07.02.18 07.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Februar 2018

DOI

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Eligibility Depression NCT00624858

Englisch

Eligibility Depression NCT00624858

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00624858
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male subjects must be 18 to 65 years of age;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
have body mass index (bmi) greater or equal to 27 and less than or to equal 43kg/m2;
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
meet criteria for major depression
Beschreibung

Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
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;
Beschreibung

Childbearing Potential Breast Feeding Absent | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
able to comply with all required study procedures and schedule;
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
able to speak and read english;
Beschreibung

Able to speak English Language | Able to read English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
willing and able to give written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
obesity of known endocrine origin
Beschreibung

Obesity of endocrine origin

Datentyp

boolean

Alias
UMLS CUI [1]
C0267992
serious medical condition
Beschreibung

Medical condition Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
history of drug or alcohol abuse or dependence
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
use of excluded concomitant medications
Beschreibung

Pharmaceutical Preparations Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
history of surgical or device (e.g. gastric banding) intervention for obesity;
Beschreibung

Obesity surgery | Medical Device Intervention Obesity | Gastric band Intervention Obesity

Datentyp

boolean

Alias
UMLS CUI [1]
C1167841
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C0184661
UMLS CUI [2,3]
C0028754
UMLS CUI [3,1]
C3854330
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0028754
history or predisposition to seizures
Beschreibung

Seizures | Predisposition Seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C0220898
UMLS CUI [2,2]
C0036572
pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
planned surgical procedure that can impact the conduct of the study;
Beschreibung

Operative Surgical Procedure Planned | Impact Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C4049986
UMLS CUI [2,2]
C0008976
use of investigational drug, device or procedure within 30 days prior to screening;
Beschreibung

Investigational New Drugs | Investigational Medical Device | Procedure Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C1517586
participation in any previous clinical trial conducted by orexigen therapeutics;
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
Beschreibung

Condition Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Ähnliche Modelle

Eligibility Depression NCT00624858

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00624858
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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