ID

13394

Description

Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00712686

Link

https://clinicaltrials.gov/show/NCT00712686

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 NCT00712686

Eligibility Schizophrenia NCT00712686

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with dsm-iv diagnosis of schizophrenia patients in acute relapse
Description

schizophrenia relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0277556
treated as outpatients for at least one continuous 3-month period during the past 12 months
Description

outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
panss total score ≥60
Description

panss score

Data type

boolean

Alias
UMLS CUI [1]
C0451383
previously responsive to neuroleptics (other than clozapine)
Description

neuroleptics

Data type

boolean

Alias
UMLS CUI [1]
C0040615
able to give informed consent and comprehend and satisfactorily comply with the protocol requirements
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an axis i (dsm-iv) diagnosis of schizoaffective disorder
Description

schizoaffective disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036337
a clinical picture and/or history that was consistent with: (a) delirium, dementia, amnestic or other cognitive disorders; (b) bipolar disorder; (c)personality disorder
Description

mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
nonresponsive to prior olanzapine therapy
Description

olanzapine response

Data type

boolean

Alias
UMLS CUI [1,1]
C0171023
UMLS CUI [1,2]
C1704632
likely to require prohibited concomitant therapy
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
dsm-iv criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
known to be allergic or hypersensitive to study drugs
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
represented a significant risk of committing suicide based on history or mental status exam
Description

suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0438696
unstable thyroid pathology and treatment within the past six months
Description

thyroid disease

Data type

boolean

Alias
UMLS CUI [1]
C0040128
a history or evidence of a medical condition that would expose the patient to an undue risk
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ecg findings
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759

Similar models

Eligibility Schizophrenia NCT00712686

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
schizophrenia relapse
Item
patients with dsm-iv diagnosis of schizophrenia patients in acute relapse
boolean
C0036341 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
outpatients
Item
treated as outpatients for at least one continuous 3-month period during the past 12 months
boolean
C0029921 (UMLS CUI [1])
panss score
Item
panss total score ≥60
boolean
C0451383 (UMLS CUI [1])
neuroleptics
Item
previously responsive to neuroleptics (other than clozapine)
boolean
C0040615 (UMLS CUI [1])
informed consent
Item
able to give informed consent and comprehend and satisfactorily comply with the protocol requirements
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
schizoaffective disorder
Item
an axis i (dsm-iv) diagnosis of schizoaffective disorder
boolean
C0036337 (UMLS CUI [1])
mental disorders
Item
a clinical picture and/or history that was consistent with: (a) delirium, dementia, amnestic or other cognitive disorders; (b) bipolar disorder; (c)personality disorder
boolean
C0004936 (UMLS CUI [1])
olanzapine response
Item
nonresponsive to prior olanzapine therapy
boolean
C0171023 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
therapy
Item
likely to require prohibited concomitant therapy
boolean
C0087111 (UMLS CUI [1])
substance abuse
Item
dsm-iv criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
boolean
C0038586 (UMLS CUI [1])
hypersensitivity
Item
known to be allergic or hypersensitive to study drugs
boolean
C0020517 (UMLS CUI [1])
suicidal
Item
represented a significant risk of committing suicide based on history or mental status exam
boolean
C0438696 (UMLS CUI [1])
thyroid disease
Item
unstable thyroid pathology and treatment within the past six months
boolean
C0040128 (UMLS CUI [1])
comorbidity
Item
a history or evidence of a medical condition that would expose the patient to an undue risk
boolean
C0009488 (UMLS CUI [1])
health status
Item
clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ecg findings
boolean
C0018759 (UMLS CUI [1])

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