0 Avaliações

ID

16907

Descrição

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00252330

Link

https://clinicaltrials.gov/show/NCT00252330

Palavras-chave

  1. 13/08/2016 13/08/2016 -
Transferido a

13 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Major Depressive Disorder NCT00252330

    Eligibility Major Depressive Disorder NCT00252330

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    main inclusion criteria:
    Descrição

    Inclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512693 (Inclusion)
    1. out-patients, 18 year and older.
    Descrição

    Out-patients, age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0029921 (Outpatients)
    SNOMED
    373864002
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    2. major depressive disorder (mdd) with a recurrentmajor depressive episode (mde) according to dsmiv-tr criteria
    Descrição

    major depressive disorder with a recurrent major depressive episode according to dsmiv-tr criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0154409 (Recurrent major depressive episodes)
    SNOMED
    268621008
    UMLS CUI [1,2]
    C0220952 (DSM-IV)
    3. duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
    Descrição

    Duration of current depressive episode

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0154409 (Recurrent major depressive episodes)
    SNOMED
    268621008
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    4. patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.
    Descrição

    Treatment or hospitalization or antidepressant treatment for a previous depressive episode

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0154409 (Recurrent major depressive episodes)
    SNOMED
    268621008
    UMLS CUI [2]
    C0003289 (Antidepressive Agents)
    SNOMED
    36236003
    LOINC
    LP18893-5
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    main exclusion criteria:
    Descrição

    Exclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    1. patients at immediate risk for suicidal behavior
    Descrição

    Suicidal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0438696 (Suicidal)
    SNOMED
    267073005
    LOINC
    LA29198-1
    2. patients with a mde with psychotic features, catatonic features, seasonal pattern or postpartum onset
    Descrição

    Major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0154413 (Recurrent depressive disorder, current episode severe with psychotic symptoms)
    SNOMED
    28475009
    UMLS CUI [2]
    C0520672 (Recurrent major depressive disorder with catatonic features)
    SNOMED
    39809009
    UMLS CUI [3]
    C0085159 (Seasonal Affective Disorder)
    SNOMED
    247803002
    UMLS CUI [4]
    C0221074 (Depression, Postpartum)
    SNOMED
    58703003
    3. the duration of the current depressive episode is greater than 2 years
    Descrição

    Duration of current depressive episode

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0154409 (Recurrent major depressive episodes)
    SNOMED
    268621008
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    4. patients whose current depressive episode is secondary to a general medical condition
    Descrição

    Current depressive episode secondary to a general medical condition

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0520619 (Mood disorder with major depressive-like episode due to general medical condition)
    SNOMED
    77486005
    5. patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
    Descrição

    Bipolar disorder, psychotic disorder, or antisocial personality disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005586 (Bipolar Disorder)
    SNOMED
    13746004
    LOINC
    MTHU026189
    UMLS CUI [2]
    C0033975 (Psychotic Disorders)
    SNOMED
    69322001
    UMLS CUI [3]
    C0003431 (Antisocial Personality Disorder)
    SNOMED
    26665006
    6. patients who have received non-pharmacologic, somatic treatments for psychiatric disease
    Descrição

    Somatic treatments

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0037646 (Psychiatric Somatic Therapies)
    SNOMED
    89560003
    7. patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
    Descrição

    Psychotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0033968 (Psychotherapy)
    SNOMED
    75516001

    Similar models

    Eligibility Major Depressive Disorder NCT00252330

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Inclusion criteria
    Item
    main inclusion criteria:
    boolean
    C1512693 (UMLS CUI [1])
    Out-patients, age
    Item
    1. out-patients, 18 year and older.
    boolean
    C0029921 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    major depressive disorder with a recurrent major depressive episode according to dsmiv-tr criteria
    Item
    2. major depressive disorder (mdd) with a recurrentmajor depressive episode (mde) according to dsmiv-tr criteria
    boolean
    C0154409 (UMLS CUI [1,1])
    C0220952 (UMLS CUI [1,2])
    Duration of current depressive episode
    Item
    3. duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
    boolean
    C0154409 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Treatment or hospitalization or antidepressant treatment for a previous depressive episode
    Item
    4. patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0154409 (UMLS CUI [1,2])
    C0003289 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion criteria
    Item
    main exclusion criteria:
    boolean
    C0680251 (UMLS CUI [1])
    Suicidal
    Item
    1. patients at immediate risk for suicidal behavior
    boolean
    C0438696 (UMLS CUI [1])
    Major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset
    Item
    2. patients with a mde with psychotic features, catatonic features, seasonal pattern or postpartum onset
    boolean
    C0154413 (UMLS CUI [1])
    C0520672 (UMLS CUI [2])
    C0085159 (UMLS CUI [3])
    C0221074 (UMLS CUI [4])
    Duration of current depressive episode
    Item
    3. the duration of the current depressive episode is greater than 2 years
    boolean
    C0154409 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Current depressive episode secondary to a general medical condition
    Item
    4. patients whose current depressive episode is secondary to a general medical condition
    boolean
    C0520619 (UMLS CUI [1])
    Bipolar disorder, psychotic disorder, or antisocial personality disorder
    Item
    5. patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
    boolean
    C0005586 (UMLS CUI [1])
    C0033975 (UMLS CUI [2])
    C0003431 (UMLS CUI [3])
    Somatic treatments
    Item
    6. patients who have received non-pharmacologic, somatic treatments for psychiatric disease
    boolean
    C0037646 (UMLS CUI [1])
    Psychotherapy
    Item
    7. patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
    boolean
    C0033968 (UMLS CUI [1])

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