ID

19265

Description

Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00088478

Link

https://clinicaltrials.gov/show/NCT00088478

Keywords

Versions (1)
  1. 12/16/16 12/16/16 -
Uploaded on

December 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00088478

English

Eligibility Schizophrenia NCT00088478

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have schizophrenia and be experiencing a psychotic episode
Description

Schizophrenia | Psychotic episode

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0338614
each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
Description

Comprehension Sufficient Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0525058
UMLS CUI [2]
C0021430
patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
Description

Study Subject Participation Status | Investigational New Drugs | olanzapine

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0171023
female patients must not be pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
Description

Genderr Medical condition | Gender Medical condition Serious | Gender Medical condition Unstable | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3843040
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3843040
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C3843040
UMLS CUI [3,3]
C0443343
UMLS CUI [4]
C0036341
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
Description

olanzapine Therapeutic procedure Resistant to

Data type

boolean

Alias
UMLS CUI [1,1]
C0171023
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332325
one or more seizures without a clear and resolved etiology is exclusionary. however, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
Description

Seizures Quantity | Etiology Unresolved

Data type

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1314792
UMLS CUI [2,2]
C0443342
treatment with clozapine within 4 weeks prior to visit 1
Description

Clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
dsm-iv or dsm-iv-tr substance (except nicotine and caffeine) dependence within the past 30 days
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
treatment with remoxipride within 6 months (180 days) prior to visit 1
Description

Remoxipride

Data type

boolean

Alias
UMLS CUI [1]
C0073047
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Similar models

Eligibility Schizophrenia NCT00088478

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Psychotic episode
Item
patients must have schizophrenia and be experiencing a psychotic episode
boolean
C0036341 (UMLS CUI [1])
C0338614 (UMLS CUI [2])
Comprehension Sufficient Protocol Compliance | Informed Consent
Item
each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
boolean
C0162340 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | olanzapine
Item
patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0171023 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
female patients must not be pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Genderr Medical condition | Gender Medical condition Serious | Gender Medical condition Unstable | Schizophrenia
Item
female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
boolean
C0079399 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C3843040 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C3843040 (UMLS CUI [3,2])
C0443343 (UMLS CUI [3,3])
C0036341 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
olanzapine Therapeutic procedure Resistant to
Item
patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
boolean
C0171023 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
Seizures Quantity | Etiology Unresolved
Item
one or more seizures without a clear and resolved etiology is exclusionary. however, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
boolean
C0036572 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1314792 (UMLS CUI [2,1])
C0443342 (UMLS CUI [2,2])
Clozapine
Item
treatment with clozapine within 4 weeks prior to visit 1
boolean
C0009079 (UMLS CUI [1])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv or dsm-iv-tr substance (except nicotine and caffeine) dependence within the past 30 days
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Remoxipride
Item
treatment with remoxipride within 6 months (180 days) prior to visit 1
boolean
C0073047 (UMLS CUI [1])
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