ID

32139

Description

A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00845026

Link

https://clinicaltrials.gov/show/NCT00845026

Keywords

Versions (1)
  1. 10/21/18 10/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00845026

English

Eligibility Schizophrenia NCT00845026

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
Description

Indication Antipsychotic Agent Change | Initiation Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0040615
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0040615
patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
Description

Hospitalization Willing | Hospital Stay Length Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0023303
UMLS CUI [2,2]
C0600109
the investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
Description

Discharge from hospital post treatment Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0586003
UMLS CUI [1,2]
C2709088
UMLS CUI [1,3]
C1517001
disease symptoms must meet a certain range as assessed by the clinician
Description

Symptoms in range

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0460094
patients must have evidence of functional impairment (i.e. social or vocational deficiency)
Description

Functional impairment | Impairment social | Impairment Occupational

Data type

boolean

Alias
UMLS CUI [1]
C4062321
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0728831
UMLS CUI [3,1]
C0221099
UMLS CUI [3,2]
C0521127
patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Description

Comprehension Study Protocol | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
patients must be able to understand the nature of the study and have given their informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are actively suicidal
Description

Patients Suicidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0438696
patients who are pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have had electroconvulsive therapy (ect) within 3 months of screening or who will have ect at any time during the study
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
Description

Angle Closure Glaucoma Uncontrolled | Seizures | Diabetic - poor control | Liver diseases | Thyroid Disease Uncontrolled | Illness Serious | Illness Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0040128
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0221423
UMLS CUI [6,2]
C0205404
UMLS CUI [7,1]
C0221423
UMLS CUI [7,2]
C0443343
patients with parkinson's disease, psychosis related to dementia or related disorders
Description

Parkinson Disease | Psychotic Disorders Relationship Dementia | Disease Related

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0497327
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0439849
patients with known human immunodeficiency virus positive (hiv+) status
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Schizophrenia NCT00845026

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
clinical diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Indication Antipsychotic Agent Change | Initiation Antipsychotic Agents
Item
patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
boolean
C3146298 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1704686 (UMLS CUI [2,1])
C0040615 (UMLS CUI [2,2])
Hospitalization Willing | Hospital Stay Length Willing
Item
patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
boolean
C0019993 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0023303 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Discharge from hospital post treatment Expected
Item
the investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
boolean
C0586003 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Symptoms in range
Item
disease symptoms must meet a certain range as assessed by the clinician
boolean
C1457887 (UMLS CUI [1,1])
C0460094 (UMLS CUI [1,2])
Functional impairment | Impairment social | Impairment Occupational
Item
patients must have evidence of functional impairment (i.e. social or vocational deficiency)
boolean
C4062321 (UMLS CUI [1])
C0221099 (UMLS CUI [2,1])
C0728831 (UMLS CUI [2,2])
C0221099 (UMLS CUI [3,1])
C0521127 (UMLS CUI [3,2])
Comprehension Study Protocol | Protocol Compliance
Item
patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
patients must be able to understand the nature of the study and have given their informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Suicidal
Item
patients who are actively suicidal
boolean
C0030705 (UMLS CUI [1,1])
C0438696 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Electroconvulsive Therapy
Item
patients who have had electroconvulsive therapy (ect) within 3 months of screening or who will have ect at any time during the study
boolean
C0013806 (UMLS CUI [1])
Angle Closure Glaucoma Uncontrolled | Seizures | Diabetic - poor control | Liver diseases | Thyroid Disease Uncontrolled | Illness Serious | Illness Unstable
Item
patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0040128 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0221423 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0221423 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
Parkinson Disease | Psychotic Disorders Relationship Dementia | Disease Related
Item
patients with parkinson's disease, psychosis related to dementia or related disorders
boolean
C0030567 (UMLS CUI [1])
C0033975 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0497327 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
HIV Seropositivity
Item
patients with known human immunodeficiency virus positive (hiv+) status
boolean
C0019699 (UMLS CUI [1])
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