0 Avaliações
ID

32043

Descrição

Quetiapine Extended Release Depression Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00640562

Link

https://clinicaltrials.gov/show/NCT00640562

Palavras-chave

Versões (1)
  1. 15/10/2018 15/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Schizophrenia NCT00640562

    Inglês

    Eligibility Schizophrenia NCT00640562

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    provision of written informed consent
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to dsm-ivtr
    Descrição

    Schizophrenia | Schizoaffective Disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0036341
    UMLS CUI [2]
    C0036337
    baseline depressive symptoms, assessed by means of ham-d (21-item) score ≥20, and ham-d item 1 score ≥2
    Descrição

    Depressive Symptoms Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressive Symptoms Hamilton rating scale for depression

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0086132
    UMLS CUI [1,2]
    C3640518
    UMLS CUI [2,1]
    C0086132
    UMLS CUI [2,2]
    C0451203
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any dsm-iv axis i disorder other than schizophrenia and schizoaffective disorder
    Descrição

    Axis I diagnosis | Exception Schizophrenia | Exception Schizoaffective Disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0270287
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0036341
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0036337
    patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other ap oral medications during the trial except for the switch period
    Descrição

    Injection of depot antipsychotic agent | Antipsychotic Agents Oral | Exception Drug Switching

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2585377
    UMLS CUI [2,1]
    C0040615
    UMLS CUI [2,2]
    C1527415
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C2936279
    use of clozapine within 28 days prior to enrollment or clozapine non responders
    Descrição

    Clozapine | Clozapine non-responder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009079
    UMLS CUI [2,1]
    C0009079
    UMLS CUI [2,2]
    C0919875
    any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
    Descrição

    Disease Clinical Significance | Patient Inappropriate Investigational New Drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [2,3]
    C0013230
    an absolute neutrophil count (anc) of ≤1.5 x 109 per liter
    Descrição

    Absolute neutrophil count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
    Descrição

    At risk for suicide | At risk for deliberate self harm | At risk of harming others

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0563664
    UMLS CUI [2]
    C1276053
    UMLS CUI [3]
    C1271966
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    Similar models

    Eligibility Schizophrenia NCT00640562

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    provision of written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Schizophrenia | Schizoaffective Disorder
    Item
    patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to dsm-ivtr
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    Depressive Symptoms Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressive Symptoms Hamilton rating scale for depression
    Item
    baseline depressive symptoms, assessed by means of ham-d (21-item) score ≥20, and ham-d item 1 score ≥2
    boolean
    C0086132 (UMLS CUI [1,1])
    C3640518 (UMLS CUI [1,2])
    C0086132 (UMLS CUI [2,1])
    C0451203 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Axis I diagnosis | Exception Schizophrenia | Exception Schizoaffective Disorder
    Item
    any dsm-iv axis i disorder other than schizophrenia and schizoaffective disorder
    boolean
    C0270287 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0036341 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0036337 (UMLS CUI [3,2])
    Injection of depot antipsychotic agent | Antipsychotic Agents Oral | Exception Drug Switching
    Item
    patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other ap oral medications during the trial except for the switch period
    boolean
    C2585377 (UMLS CUI [1])
    C0040615 (UMLS CUI [2,1])
    C1527415 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C2936279 (UMLS CUI [3,2])
    Clozapine | Clozapine non-responder
    Item
    use of clozapine within 28 days prior to enrollment or clozapine non responders
    boolean
    C0009079 (UMLS CUI [1])
    C0009079 (UMLS CUI [2,1])
    C0919875 (UMLS CUI [2,2])
    Disease Clinical Significance | Patient Inappropriate Investigational New Drugs
    Item
    any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
    boolean
    C0012634 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C0013230 (UMLS CUI [2,3])
    Absolute neutrophil count
    Item
    an absolute neutrophil count (anc) of ≤1.5 x 109 per liter
    boolean
    C0948762 (UMLS CUI [1])
    At risk for suicide | At risk for deliberate self harm | At risk of harming others
    Item
    patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
    boolean
    C0563664 (UMLS CUI [1])
    C1276053 (UMLS CUI [2])
    C1271966 (UMLS CUI [3])
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