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ID

43548

Description

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

Keywords

Versions (2)
  1. 31-05-16 31-05-16 -
  2. 20-09-21 20-09-21 -
Uploaded on

20 september 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Major Depressive Disorder NCT02129751

    English

    Eligibility Major Depressive Disorder NCT02129751

    1 forms  
    Inclusion Criteria
    Description

    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).
    Description

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

    Data type

    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).
    Description

    Major Depressive Disorder Diagnostic Criteria Met DSM-IV

    Data type

    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).
    Description

    Depressive episode Duration

    Data type

    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).
    Description

    Depression in children Rating scale Score

    Data type

    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).
    Description

    Clinical Global Impression Questionnaire

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3639708
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Inability to swallow oral medication | Difficulty

    Data type

    boolean

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

    Hypersensitivity Bupropion hydrobromide

    Data type

    boolean

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

    Pregnancy | Pregnancy, Planned | Breast Feeding

    Data type

    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
    Description

    Childbearing Potential Age | Contraceptive methods Unable

    Data type

    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
    Description

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

    Data type

    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
    Description

    Hospitalization Requirement At risk

    Data type

    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
    Description

    Epilepsy | Seizures | Craniocerebral Trauma

    Data type

    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
    Description

    medical condition Clinical Significance | LABORATORY ABNORMALITIES

    Data type

    boolean

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

    ECG abnormality | Physical Examination Abnormal Finding

    Data type

    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.
    Description

    Body Weight | weight percentile for age

    Data type

    boolean

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

    Eligibility Major Depressive Disorder NCT02129751

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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