0 Ratings

ID

13393

Description

Janssen - Glucose Regulation/Risp/Olanz; ODM derived from: https://clinicaltrials.gov/show/NCT00205738

Link

https://clinicaltrials.gov/show/NCT00205738

Keywords

  1. 2/10/16 2/10/16 -
Uploaded on

February 10, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Schizophrenia NCT00205738

    Eligibility Schizophrenia NCT00205738

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients: meets dsm-iv criteria for schizophrenia, any type, or schizoaffective disorder;
    Description

    schizophrenia or schizoaffective disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036341
    UMLS CUI [2]
    C0036337
    2. aged 18 to 60 years;
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. able to give informed consent;
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    4. no medication changes for 2 weeks prior to and during the period of study; 5. patients: currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic.
    Description

    medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. controls: axis i psychiatric disorder criteria met except for substance use disorders as below;
    Description

    psychiatric disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    2. meets dsm-iv criteria for the diagnoses of substance abuse or dependence within the past six months;
    Description

    substance abuse

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    3. involuntary legal status (as per missouri law);
    Description

    legal status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0580275
    4. the presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis; the following conditions are currently identified: insulin- or non-insulin-dependent diabetes mellitus; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise; any diagnosed respiratory condition causing documented or clinically recognized hypoxia; pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
    Description

    pregnancy, medication, comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0013227
    UMLS CUI [3]
    C0009488
    5. meets dsm-iv criteria for mental retardation (mild or worse).
    Description

    mental retardation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0025362

    Similar models

    Eligibility Schizophrenia NCT00205738

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    schizophrenia or schizoaffective disorder
    Item
    1. patients: meets dsm-iv criteria for schizophrenia, any type, or schizoaffective disorder;
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    age
    Item
    2. aged 18 to 60 years;
    boolean
    C0001779 (UMLS CUI [1])
    informed consent
    Item
    3. able to give informed consent;
    boolean
    C0021430 (UMLS CUI [1])
    medication
    Item
    4. no medication changes for 2 weeks prior to and during the period of study; 5. patients: currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic.
    boolean
    C0013227 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    psychiatric disorder
    Item
    1. controls: axis i psychiatric disorder criteria met except for substance use disorders as below;
    boolean
    C0004936 (UMLS CUI [1])
    substance abuse
    Item
    2. meets dsm-iv criteria for the diagnoses of substance abuse or dependence within the past six months;
    boolean
    C0038586 (UMLS CUI [1])
    legal status
    Item
    3. involuntary legal status (as per missouri law);
    boolean
    C0580275 (UMLS CUI [1])
    pregnancy, medication, comorbidity
    Item
    4. the presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis; the following conditions are currently identified: insulin- or non-insulin-dependent diabetes mellitus; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise; any diagnosed respiratory condition causing documented or clinically recognized hypoxia; pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
    boolean
    C0032961 (UMLS CUI [1])
    C0013227 (UMLS CUI [2])
    C0009488 (UMLS CUI [3])
    mental retardation
    Item
    5. meets dsm-iv criteria for mental retardation (mild or worse).
    boolean
    C0025362 (UMLS CUI [1])

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