ID

43548

Beschrijving

Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02129751

Link

https://clinicaltrials.gov/show/NCT02129751

Trefwoorden

Versies (2)
  1. 31-05-16 31-05-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02129751

Engels

Eligibility Major Depressive Disorder NCT02129751

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
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).
Beschrijving

Age | Outpatients | Informed Consent | parent | Health Insurance Portability and Accountability Act

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0029921
UMLS CUI [3]
C0021430
UMLS CUI [4]
C0030551
UMLS CUI [5]
C0600593
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).
Beschrijving

Major Depressive Disorder Diagnostic Criteria Met DSM-IV

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C3897171
UMLS CUI [1,3]
C0220952
4. current depressive episode of at least 4 weeks' duration as noted in the subject's history (screening visit 1).
Beschrijving

Depressive episode Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
5. total cdrs-r raw score ≥45 at both the screening and baseline visits (visits 1 and 2) (see appendix 17.3).
Beschrijving

Depression in children Rating scale Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C3826462
UMLS CUI [1,2]
C0681889
UMLS CUI [1,3]
C0449820
6. cgi-s score of ≥4 at the baseline visit (visit 2) (see appendix 17.4).
Beschrijving

Clinical Global Impression Questionnaire

Datatype

boolean

Alias
UMLS CUI [1]
C3639708
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
are unable to swallow medications without difficulty
Beschrijving

Inability to swallow oral medication | Difficulty

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221470
UMLS CUI [1,2]
C0175795
UMLS CUI [2]
C0332218
• have known hypersensitivity to bupropion hydrobromide
Beschrijving

Hypersensitivity Bupropion hydrobromide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2316497
are pregnant or planning to get pregnant or are lactating
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
women of childbearing age unable to use at least one method of effective contraception for the duration of the study
Beschrijving

Childbearing Potential Age | Contraceptive methods Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1299582
previous history of attempted suicide are unable to understand and communicate effectively with parent, investigator, and study coordinator
Beschrijving

Previous known suicide attempt | Unable to communicate Parent Clinical Investigators Study Coordinator

Datatype

boolean

Alias
UMLS CUI [1]
C0277666
UMLS CUI [2,1]
C0566000
UMLS CUI [2,2]
C0030551
UMLS CUI [2,3]
C0008961
UMLS CUI [2,4]
C1710220
are at immediate risk of requiring hospitalization, in the investigator's opinion
Beschrijving

Hospitalization Requirement At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1444641
have current seizure disorder or history of seizures or head trauma
Beschrijving

Epilepsy | Seizures | Craniocerebral Trauma

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0018674
have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities
Beschrijving

medical condition Clinical Significance | LABORATORY ABNORMALITIES

Datatype

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C1853129
have ecg or physical examination abnormality at screening
Beschrijving

ECG abnormality | Physical Examination Abnormal Finding

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C2826636
have body weight less than the 3rd percentile or greater than the 97th percentile for age.
Beschrijving

Body Weight | weight percentile for age

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C0517416
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Similar models

Eligibility Major Depressive Disorder NCT02129751

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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