ID

22309

Description

Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?; ODM derived from: https://clinicaltrials.gov/show/NCT00616915

Link

https://clinicaltrials.gov/show/NCT00616915

Keywords

Versions (1)
  1. 5/29/17 5/29/17 -
Uploaded on

May 29, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Mood Disorder NCT00616915

    English

    Eligibility Mood Disorder NCT00616915

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. signed patient informed consent;
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    2. patients with major depressive disorders (dsm-iv-tr - criteria used);
    Description

    DSM IV major depressive disorder

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683 (Major Depressive Disorder)
    SNOMED
    370143000
    UMLS CUI [1,2]
    C2199206 (DSM-IV criteria for major depressive diagnosis documented)
    3. out-patients;
    Description

    outpatients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029921 (Outpatients)
    SNOMED
    373864002
    4. males or females over 18 years of age;
    Description

    age, gender

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    5. patients currently using wellbutrin sr.
    Description

    wellbutrin sr

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0724393 (Wellbutrin SR)
    UMLS CUI [1,2]
    C0746467 (Current Medication)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. bipolar disorder patients;
    Description

    bipolar disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005586 (Bipolar Disorder)
    SNOMED
    13746004
    LOINC
    MTHU026189
    2. actively suicidal patients;
    Description

    actively suicidal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0438696 (Suicidal)
    SNOMED
    267073005
    LOINC
    LA29198-1
    3. schizophrenia, schizoaffective or other psychotic disorder;
    Description

    schizophrenia, schizoaffective or other psychotic disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    UMLS CUI [2]
    C0036337 (Schizoaffective Disorder)
    SNOMED
    191567000
    UMLS CUI [3]
    C0033975 (Psychotic Disorders)
    SNOMED
    69322001
    4. pregnant women, as by pregnancy test at the beginning of the study;
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    5. women in childbearing age, refusing to use appropriate contraception, or breastfeeding mothers;
    Description

    women in childbearing age refusing to use contraception, breastfeeding mothers

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1960468 (Female of child bearing age)
    SNOMED
    427504007
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    6. patients with known hypersensitivity to bupropion;
    Description

    hypersensitivity to bupropion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0085208 (bupropion)
    SNOMED
    96199001
    7. patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety;
    Description

    severe or unstable comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    UMLS CUI [1,2]
    C0009488 (Comorbidity)
    UMLS CUI [2,1]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,2]
    C0009488 (Comorbidity)
    8. ect or tms treatments within the last three months;
    Description

    ect or tms treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013806 (Electroconvulsive Therapy)
    SNOMED
    23835007
    UMLS CUI [2]
    C0436548 (Transcranial magnetic stimulation)
    SNOMED
    264603002
    9. patients who did not respond to previous treatment with bupropion;
    Description

    non-responder bupropion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0919875 (Therapy non-responder)
    UMLS CUI [1,2]
    C0085208 (bupropion)
    SNOMED
    96199001
    10. patients with history of seizure disorder;
    Description

    seizure disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    11. patients with history of eating disorders (e.g. bulimia, anorexia nervosa);
    Description

    eating disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013473 (Eating Disorders)
    SNOMED
    72366004
    12. patients using sleep aiding medication (benzodiazepines, barbiturates).
    Description

    sleep aiding medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2054158 (taking medication to help sleep)
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    Similar models

    Eligibility Mood Disorder NCT00616915

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    1. signed patient informed consent;
    boolean
    C0021430 (UMLS CUI [1])
    DSM IV major depressive disorder
    Item
    2. patients with major depressive disorders (dsm-iv-tr - criteria used);
    boolean
    C1269683 (UMLS CUI [1,1])
    C2199206 (UMLS CUI [1,2])
    outpatients
    Item
    3. out-patients;
    boolean
    C0029921 (UMLS CUI [1])
    age, gender
    Item
    4. males or females over 18 years of age;
    boolean
    C0001779 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    wellbutrin sr
    Item
    5. patients currently using wellbutrin sr.
    boolean
    C0724393 (UMLS CUI [1,1])
    C0746467 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    bipolar disorder
    Item
    1. bipolar disorder patients;
    boolean
    C0005586 (UMLS CUI [1])
    actively suicidal
    Item
    2. actively suicidal patients;
    boolean
    C0438696 (UMLS CUI [1])
    schizophrenia, schizoaffective or other psychotic disorder
    Item
    3. schizophrenia, schizoaffective or other psychotic disorder;
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    C0033975 (UMLS CUI [3])
    pregnancy
    Item
    4. pregnant women, as by pregnancy test at the beginning of the study;
    boolean
    C0032961 (UMLS CUI [1])
    women in childbearing age refusing to use contraception, breastfeeding mothers
    Item
    5. women in childbearing age, refusing to use appropriate contraception, or breastfeeding mothers;
    boolean
    C1960468 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2])
    hypersensitivity to bupropion
    Item
    6. patients with known hypersensitivity to bupropion;
    boolean
    C0020517 (UMLS CUI [1,1])
    C0085208 (UMLS CUI [1,2])
    severe or unstable comorbidity
    Item
    7. patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety;
    boolean
    C0443343 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [2,1])
    C0009488 (UMLS CUI [2,2])
    ect or tms treatment
    Item
    8. ect or tms treatments within the last three months;
    boolean
    C0013806 (UMLS CUI [1])
    C0436548 (UMLS CUI [2])
    non-responder bupropion
    Item
    9. patients who did not respond to previous treatment with bupropion;
    boolean
    C0919875 (UMLS CUI [1,1])
    C0085208 (UMLS CUI [1,2])
    seizure disorder
    Item
    10. patients with history of seizure disorder;
    boolean
    C0014544 (UMLS CUI [1])
    eating disorders
    Item
    11. patients with history of eating disorders (e.g. bulimia, anorexia nervosa);
    boolean
    C0013473 (UMLS CUI [1])
    sleep aiding medication
    Item
    12. patients using sleep aiding medication (benzodiazepines, barbiturates).
    boolean
    C2054158 (UMLS CUI [1])
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