ID
29022
Description
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder
Keywords
Versions (1)
- 2/21/18 2/21/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 21, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder [ID 101497]
Visit 1 (Screening): Eligibility Criteria
- StudyEvent: ODM
Description
Screening Visit Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Differential diagnosis higher propability
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011906
- UMLS CUI [1,2]
- C0033204
Description
Medical history of manic disorders
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0024713
Description
Schizophrenia or other psychotic disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0036341
- UMLS CUI [2]
- C0033975
Description
DSM-IV | non-responsiveness to pharmacotherapy | non-compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C0220952
- UMLS CUI [2,1]
- C0013216
- UMLS CUI [2,2]
- C3845159
- UMLS CUI [3]
- C0457432
Description
anorexia nervosa | bulimia
Data type
boolean
Alias
- UMLS CUI [1]
- C0003125
- UMLS CUI [2]
- C2267227
Description
Reason for depressive symptoms due to physiological effects of a general medical condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0086132
- UMLS CUI [1,2]
- C2359476
Description
homicidal risk, suicidal risk, suicide attempt
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035647
- UMLS CUI [1,2]
- C0745031
- UMLS CUI [2]
- C0563664
- UMLS CUI [3]
- C0277662
- UMLS CUI [4]
- C0038663
Description
seizure disorder | brain injury | undergoing abrupt discontinuation of alcohol or sedatives
Data type
boolean
Alias
- UMLS CUI [1]
- C0014544
- UMLS CUI [2]
- C0270611
- UMLS CUI [3]
- C0236663
- UMLS CUI [4,1]
- C0457454
- UMLS CUI [4,2]
- C0036557
Description
myocardial infarction | uncontrolled hypertension | unstable heart disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0027051
- UMLS CUI [2]
- C1868885
- UMLS CUI [3,1]
- C0018799
- UMLS CUI [3,2]
- C0443343
Description
Unstable medical disorder | bupropion hydrochloride or venlafaxine hydrochloride interaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0443343
- UMLS CUI [2,1]
- C0700563
- UMLS CUI [2,2]
- C0687133
- UMLS CUI [3,1]
- C0078569
- UMLS CUI [3,2]
- C0687133
Description
medically significant adverse effects bupropion hydrochloride | medically significant adverse effects venlafaxine hydrochloride |
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700563
- UMLS CUI [1,2]
- C0879626
- UMLS CUI [2,1]
- C0078569
- UMLS CUI [2,2]
- C0879626
Description
bupropion hydrochloride or venlafaxine hydrochloride interaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700563
- UMLS CUI [1,2]
- C0687133
- UMLS CUI [2,1]
- C0078569
- UMLS CUI [2,2]
- C0687133
Description
bupropion hydrochloride | venlafaxine hydrochloride
Data type
boolean
Alias
- UMLS CUI [1]
- C0700563
- UMLS CUI [2]
- C0078569
Description
psychotherapy
Data type
boolean
Alias
- UMLS CUI [1]
- C0033968
Description
electroconvulsive therapy | transcranial magnetic stimulation
Data type
boolean
Alias
- UMLS CUI [1]
- C0013806
- UMLS CUI [2]
- C0436548
Description
failed adequate courses of pharmacotherapy | antidepressants
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [2,1]
- C0003289
- UMLS CUI [2,2]
- C1705242
Description
Note - subjects must be told to avoid consumption of alcoholic beverages for at least 8 hours prior to their Screening Visit. A positive urine test may not be repeated.
Data type
boolean
Alias
- UMLS CUI [1]
- C0202274
- UMLS CUI [2]
- C0038586
Description
Note: Subjects maintained on thyroid medication must be euthyroid for a period of at least 3 months prior to the Screening Visit
Data type
boolean
Alias
- UMLS CUI [1]
- C0438215
Description
heart diseases
Data type
boolean
Alias
- UMLS CUI [1]
- C0018799
Description
systolic blood pressure | diastolic blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Description
pregnancy | lactation | pregnancy, planned
Data type
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Description
Clinical trial participation
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Compliance behaviour
Data type
boolean
Alias
- UMLS CUI [1]
- C1321605
Similar models
Visit 1 (Screening): Eligibility Criteria
- StudyEvent: ODM
C0001779 (UMLS CUI [2])
C1269683 (UMLS CUI [2,1])
C0443287 (UMLS CUI [2,2])
C1298908 (UMLS CUI [1,2])
C0033204 (UMLS CUI [1,2])
C0024713 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2])
C0013216 (UMLS CUI [2,1])
C3845159 (UMLS CUI [2,2])
C0457432 (UMLS CUI [3])
C2267227 (UMLS CUI [2])
C2359476 (UMLS CUI [1,2])
C0745031 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C0277662 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
C0270611 (UMLS CUI [2])
C0236663 (UMLS CUI [3])
C0457454 (UMLS CUI [4,1])
C0036557 (UMLS CUI [4,2])
C1868885 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0443343 (UMLS CUI [1,2])
C0700563 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0078569 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
C0879626 (UMLS CUI [1,2])
C0078569 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0687133 (UMLS CUI [1,2])
C0078569 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0078569 (UMLS CUI [2])
C0436548 (UMLS CUI [2])
C0231175 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C0038586 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])