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43548

Beschreibung

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

Stichworte

Versionen (2)
  1. 31.05.16 31.05.16 -
  2. 20.09.21 20.09.21 -
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20. September 2021

DOI

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Creative Commons BY 4.0
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    Eligibility Major Depressive Disorder NCT02129751

    Englisch

    Eligibility Major Depressive Disorder NCT02129751

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    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).
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2]
    C0029921 (Outpatients)
    SNOMED
    373864002
    UMLS CUI [3]
    C0021430 (Informed Consent)
    UMLS CUI [4]
    C0030551 (parent)
    SNOMED
    40683002
    LOINC
    LA30680-5
    UMLS CUI [5]
    C0600593 (Health Insurance Portability and Accountability Act)
    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).
    Beschreibung

    Major Depressive Disorder Diagnostic Criteria Met DSM-IV

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683 (Major Depressive Disorder)
    SNOMED
    370143000
    UMLS CUI [1,2]
    C3897171 (Which Diagnostic Criteria Met)
    UMLS CUI [1,3]
    C0220952 (DSM-IV)
    4. current depressive episode of at least 4 weeks' duration as noted in the subject's history (screening visit 1).
    Beschreibung

    Depressive episode Duration

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0349217 (Depressive episode, unspecified)
    SNOMED
    871840004
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    5. total cdrs-r raw score ≥45 at both the screening and baseline visits (visits 1 and 2) (see appendix 17.3).
    Beschreibung

    Depression in children Rating scale Score

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3826462 (Depression in children)
    UMLS CUI [1,2]
    C0681889 (rating scale)
    UMLS CUI [1,3]
    C0449820 (Score)
    SNOMED
    246262008
    LOINC
    MTHU024701
    6. cgi-s score of ≥4 at the baseline visit (visit 2) (see appendix 17.4).
    Beschreibung

    Clinical Global Impression Questionnaire

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3639708 (Clinical global impression scale)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    are unable to swallow medications without difficulty
    Beschreibung

    Inability to swallow oral medication | Difficulty

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221470 (Aphagia)
    SNOMED
    60818005
    LOINC
    LA18261-0
    UMLS CUI [1,2]
    C0175795 (Oral Medication)
    UMLS CUI [2]
    C0332218 (Difficult (qualifier value))
    SNOMED
    52925006
    LOINC
    LA14626-8
    • have known hypersensitivity to bupropion hydrobromide
    Beschreibung

    Hypersensitivity Bupropion hydrobromide

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C2316497 (bupropion hydrobromide)
    SNOMED
    431408005
    are pregnant or planning to get pregnant or are lactating
    Beschreibung

    Pregnancy | Pregnancy, Planned | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0032992 (Pregnancy, Planned)
    SNOMED
    169565003
    UMLS CUI [3]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    women of childbearing age unable to use at least one method of effective contraception for the duration of the study
    Beschreibung

    Childbearing Potential Age | Contraceptive methods Unable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2,1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2,2]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    previous history of attempted suicide are unable to understand and communicate effectively with parent, investigator, and study coordinator
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0277666 (Previous known suicide attempt)
    SNOMED
    23233009
    UMLS CUI [2,1]
    C0566000 (Unable to communicate)
    SNOMED
    288576002
    UMLS CUI [2,2]
    C0030551 (parent)
    SNOMED
    40683002
    LOINC
    LA30680-5
    UMLS CUI [2,3]
    C0008961 (Clinical Investigators)
    UMLS CUI [2,4]
    C1710220 (Research study coordinator)
    SNOMED
    768734005
    are at immediate risk of requiring hospitalization, in the investigator's opinion
    Beschreibung

    Hospitalization Requirement At risk

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C1514873 (Requirement)
    UMLS CUI [1,3]
    C1444641 (At risk)
    SNOMED
    410519009
    LOINC
    LA19952-3
    have current seizure disorder or history of seizures or head trauma
    Beschreibung

    Epilepsy | Seizures | Craniocerebral Trauma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    UMLS CUI [2]
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    UMLS CUI [3]
    C0018674 (Craniocerebral Trauma)
    SNOMED
    82271004
    have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities
    Beschreibung

    medical condition Clinical Significance | LABORATORY ABNORMALITIES

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1699700 (medical condition category)
    UMLS CUI [1,2]
    C2826293 (Clinical Significance)
    UMLS CUI [2]
    C1853129 (LABORATORY ABNORMALITIES)
    have ecg or physical examination abnormality at screening
    Beschreibung

    ECG abnormality | Physical Examination Abnormal Finding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    UMLS CUI [2]
    C2826636 (Physical Examination Abnormal Finding)
    have body weight less than the 3rd percentile or greater than the 97th percentile for age.
    Beschreibung

    Body Weight | weight percentile for age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    UMLS CUI [2]
    C0517416 (weight percentile for age)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Major Depressive Disorder NCT02129751

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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