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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