ID

19272

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00148447

Nyckelord

Versioner (1)
  1. 2016-12-17 2016-12-17 -
Uppladdad den

17 december 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00148447

Engelsk

Eligibility Schizophrenia NCT00148447

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic schizophrenia patients,
Beskrivning

Chronic schizophrenia

Datatyp

boolean

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
medicated,
Beskrivning

Medicated

Datatyp

boolean

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

inpatient | Outpatients | Antipsychotic Agents Dose Stable

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Positive and negative syndrome scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451383
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Comorbidity | Manic Disorder | Major Depressive Disorder

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
lactation,
Beskrivning

Breast Feeding

Datatyp

boolean

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

Renal Insufficiency | Hepatic Insufficiency

Datatyp

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.
Beskrivning

Hypersensitivity Cipramil | Hypersensitivity Selective Serotonin Reuptake Inhibitors

Datatyp

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".
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent Removed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0849355
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Similar models

Eligibility Schizophrenia NCT00148447

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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