ID

19362

Description

Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00485901

Link

https://clinicaltrials.gov/show/NCT00485901

Keywords

Versions (1)
  1. 12/21/16 12/21/16 -
Uploaded on

December 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00485901

English

Eligibility Schizophrenia NCT00485901

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients, between the ages of 18 and 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in dsm-iv
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with im medication. investigator must believe that it is safe to administer im olanzapine and im comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of olanzapine im or the comparator agent)
Description

Agitated Clinical | Indication Pharmaceutical Preparations Intramuscular | olanzapine Intramuscular | Comparator Drug Intramuscular | drug safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0085631
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1556154
UMLS CUI [3,1]
C0171023
UMLS CUI [3,2]
C1556154
UMLS CUI [4,1]
C2347178
UMLS CUI [4,2]
C1556154
UMLS CUI [5]
C0678800
subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
Description

Illness caused by Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0038586
patient must be hospitalized during the study
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous participation (treatment with study drug) in a lilly sponsored intra-muscular olanzapine clinical trial
Description

Study Subject Participation Status | Clinical Trial olanzapine Intramuscular

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0171023
UMLS CUI [2,3]
C1556154
serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
Description

Illness Unstable Serious | Cessation of life Anticipated | Disease Intensive care unit Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0011065
UMLS CUI [2,2]
C3840775
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0021708
UMLS CUI [3,3]
C3840775
have a known diagnosis of dementia of any type, as defined in the dsm-iv or dsm-iv-tr
Description

Dementia Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
documented history of allergic reaction to study medication(s)
Description

Allergic Reaction Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
Description

Injection of depot antipsychotic agent

Data type

boolean

Alias
UMLS CUI [1]
C2585377
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Similar models

Eligibility Schizophrenia NCT00485901

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients, between the ages of 18 and 65
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in dsm-iv
boolean
C0036341 (UMLS CUI [1])
Agitated Clinical | Indication Pharmaceutical Preparations Intramuscular | olanzapine Intramuscular | Comparator Drug Intramuscular | drug safety
Item
patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with im medication. investigator must believe that it is safe to administer im olanzapine and im comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of olanzapine im or the comparator agent)
boolean
C0085631 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1556154 (UMLS CUI [2,3])
C0171023 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2347178 (UMLS CUI [4,1])
C1556154 (UMLS CUI [4,2])
C0678800 (UMLS CUI [5])
Illness caused by Substance Use Disorders
Item
subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
boolean
C0221423 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0038586 (UMLS CUI [1,3])
Hospitalization
Item
patient must be hospitalized during the study
boolean
C0019993 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial olanzapine Intramuscular
Item
previous participation (treatment with study drug) in a lilly sponsored intra-muscular olanzapine clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0171023 (UMLS CUI [2,2])
C1556154 (UMLS CUI [2,3])
Illness Unstable Serious | Cessation of life Anticipated | Disease Intensive care unit Anticipated
Item
serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0011065 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0021708 (UMLS CUI [3,2])
C3840775 (UMLS CUI [3,3])
Dementia Type Any
Item
have a known diagnosis of dementia of any type, as defined in the dsm-iv or dsm-iv-tr
boolean
C0497327 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Allergic Reaction Investigational New Drugs
Item
documented history of allergic reaction to study medication(s)
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Injection of depot antipsychotic agent
Item
treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
boolean
C2585377 (UMLS CUI [1])
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