ID

19272

Description

The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00148447

Link

https://clinicaltrials.gov/show/NCT00148447

Keywords

Versions (1)
  1. 12/17/16 12/17/16 -
Uploaded on

December 17, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Schizophrenia NCT00148447

English

Eligibility Schizophrenia NCT00148447

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic schizophrenia patients,
Description

Chronic schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0221765
age <60,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
medicated,
Description

Medicated

Data type

boolean

Alias
UMLS CUI [1]
C3812868
inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
Description

inpatient | Outpatients | Antipsychotic Agents Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
patients will be clinically stable and free of any additional axis i diagnosis or significant medical illnesses before enrollment into the study.
Description

Patients Clinical Stable | Axis I diagnosis Free of | Illness Significant Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0270287
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0332296
a positive and negative syndrome scale (panss) score of 50 or above will be required for entry to the study.
Description

Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C0451383
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
comorbidity with mania or major depression,
Description

Comorbidity | Manic Disorder | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0024713
UMLS CUI [3]
C1269683
pregnancy,
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
lactation,
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
impaired renal or hepatic function,
Description

Renal Insufficiency | Hepatic Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C1306571
history of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (ssri) group.
Description

Hypersensitivity Cipramil | Hypersensitivity Selective Serotonin Reuptake Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0591259
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0360105
additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and cgi scores of "condition much worsened".
Description

Mental Retardation | Condition organic | Brain Neoplasms | Drug abuse | Condition Psychiatric Exacerbated Severe | Suicide attempt | Psychotic Disorders Exacerbated Severe | Hospitalization security High | Clinical impression | Clinical Global Impression Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0747055
UMLS CUI [3]
C0006118
UMLS CUI [4]
C0013146
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0205487
UMLS CUI [5,3]
C1444749
UMLS CUI [5,4]
C0205082
UMLS CUI [6]
C0038663
UMLS CUI [7,1]
C0033975
UMLS CUI [7,2]
C1444749
UMLS CUI [7,3]
C0205082
UMLS CUI [8,1]
C0019993
UMLS CUI [8,2]
C3858932
UMLS CUI [8,3]
C0205250
UMLS CUI [9]
C2973287
UMLS CUI [10]
C3639708
patients will be excluded during the study if they will remove their informed consent.
Description

Informed Consent Removed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0849355
Back to the top of the page

Similar models

Eligibility Schizophrenia NCT00148447

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic schizophrenia
Item
chronic schizophrenia patients,
boolean
C0221765 (UMLS CUI [1])
Age
Item
age <60,
boolean
C0001779 (UMLS CUI [1])
Medicated
Item
medicated,
boolean
C3812868 (UMLS CUI [1])
inpatient | Outpatients | Antipsychotic Agents Dose Stable
Item
inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Patients Clinical Stable | Axis I diagnosis Free of | Illness Significant Free of
Item
patients will be clinically stable and free of any additional axis i diagnosis or significant medical illnesses before enrollment into the study.
boolean
C0030705 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0270287 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Positive and negative syndrome scale
Item
a positive and negative syndrome scale (panss) score of 50 or above will be required for entry to the study.
boolean
C0451383 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity | Manic Disorder | Major Depressive Disorder
Item
comorbidity with mania or major depression,
boolean
C0009488 (UMLS CUI [1])
C0024713 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
Pregnancy
Item
pregnancy,
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactation,
boolean
C0006147 (UMLS CUI [1])
Renal Insufficiency | Hepatic Insufficiency
Item
impaired renal or hepatic function,
boolean
C1565489 (UMLS CUI [1])
C1306571 (UMLS CUI [2])
Hypersensitivity Cipramil | Hypersensitivity Selective Serotonin Reuptake Inhibitors
Item
history of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (ssri) group.
boolean
C0020517 (UMLS CUI [1,1])
C0591259 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0360105 (UMLS CUI [2,2])
Mental Retardation | Condition organic | Brain Neoplasms | Drug abuse | Condition Psychiatric Exacerbated Severe | Suicide attempt | Psychotic Disorders Exacerbated Severe | Hospitalization security High | Clinical impression | Clinical Global Impression Questionnaire
Item
additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and cgi scores of "condition much worsened".
boolean
C0025362 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0747055 (UMLS CUI [2,2])
C0006118 (UMLS CUI [3])
C0013146 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0205487 (UMLS CUI [5,2])
C1444749 (UMLS CUI [5,3])
C0205082 (UMLS CUI [5,4])
C0038663 (UMLS CUI [6])
C0033975 (UMLS CUI [7,1])
C1444749 (UMLS CUI [7,2])
C0205082 (UMLS CUI [7,3])
C0019993 (UMLS CUI [8,1])
C3858932 (UMLS CUI [8,2])
C0205250 (UMLS CUI [8,3])
C2973287 (UMLS CUI [9])
C3639708 (UMLS CUI [10])
Informed Consent Removed
Item
patients will be excluded during the study if they will remove their informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0849355 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial