ID

32045

Descripción

Genetic Expression in Schizophrenics Treated With SSRI Augmentation: Relationship to Clinical and Cognitive Function; ODM derived from: https://clinicaltrials.gov/show/NCT00645580

Link

https://clinicaltrials.gov/show/NCT00645580

Palabras clave

Versiones (1)
  1. 15/10/18 15/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00645580

Inglés

Eligibility Schizophrenia NCT00645580

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-65
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
a diagnosis of schizophrenia (dsm-ivtr)
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
antipsychotic dose unchanged for at least 2 weeks prior to study
Descripción

Antipsychotic Agent Dose unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
sans score>= 3 on at least one of the global measures of affective blunting, alogia or avolition.
Descripción

Rating scale Schizophrenia Symptoms Negative | Affective blunting | Alogia | Avolition

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C1513916
UMLS CUI [2]
C0860608
UMLS CUI [3]
C0003537
UMLS CUI [4]
C3495892
knowledge of hebrew
Descripción

Knowledge Hebrew language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376554
UMLS CUI [1,2]
C0018863
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
dementia or other serious neurological disorders
Descripción

Dementia | Nervous system disorder Serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205404
history of alcohol or drug use
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
patients with a legal guardian
Descripción

Patient Has Legal Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
UMLS CUI [1,3]
C0023226
patients involuntarily hospitalized by order of the district psychiatrist
Descripción

Involuntary Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0745037
use of antidepressants within 1 month of the study
Descripción

Antidepressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003289
renal or hepatic disorder
Descripción

Kidney Diseases | Liver diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
patients with upper gi bleeds
Descripción

Upper gastrointestinal hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041909
patients with siadh syndrome
Descripción

Inappropriate ADH Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021141
pregnant woman
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
criteria for the cessation of the study after initial commencement:
Descripción

Criteria Cessation Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1880019
UMLS CUI [1,3]
C0008976
severe adverse events (including but not only gi, cardiovascular, neurologic, hematologic or urologic severe adverse events)
Descripción

Adverse events Severe | Adverse events Gastrointestinal Severe | Adverse events Cardiovascular Severe | Adverse events Neurologic Severe | Adverse events Hematologic Severe | Adverse events Urologic Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0521362
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C3887460
UMLS CUI [3,3]
C0205082
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C0205494
UMLS CUI [4,3]
C0205082
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C0205488
UMLS CUI [5,3]
C0205082
UMLS CUI [6,1]
C0877248
UMLS CUI [6,2]
C0042077
UMLS CUI [6,3]
C0205082
emergent suicidality
Descripción

Emergency Suicidality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2745965
UMLS CUI [1,2]
C3166387
emergence of hypomanic or manic symptoms
Descripción

Emergency Symptoms Hypomania | Emergency Manic symptom

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2745965
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0241934
UMLS CUI [2,1]
C2745965
UMLS CUI [2,2]
C0746402
if the subject requests to stop
Descripción

Cessation Requested by patient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1880019
UMLS CUI [1,2]
C0332153
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Similar models

Eligibility Schizophrenia NCT00645580

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-65
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
a diagnosis of schizophrenia (dsm-ivtr)
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agent Dose unchanged
Item
antipsychotic dose unchanged for at least 2 weeks prior to study
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Rating scale Schizophrenia Symptoms Negative | Affective blunting | Alogia | Avolition
Item
sans score>= 3 on at least one of the global measures of affective blunting, alogia or avolition.
boolean
C0681889 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1513916 (UMLS CUI [1,4])
C0860608 (UMLS CUI [2])
C0003537 (UMLS CUI [3])
C3495892 (UMLS CUI [4])
Knowledge Hebrew language
Item
knowledge of hebrew
boolean
C0376554 (UMLS CUI [1,1])
C0018863 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Dementia | Nervous system disorder Serious
Item
dementia or other serious neurological disorders
boolean
C0497327 (UMLS CUI [1])
C0027765 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Substance Use Disorders
Item
history of alcohol or drug use
boolean
C0038586 (UMLS CUI [1])
Patient Has Legal Guardian
Item
patients with a legal guardian
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
C0023226 (UMLS CUI [1,3])
Involuntary Hospitalization
Item
patients involuntarily hospitalized by order of the district psychiatrist
boolean
C0745037 (UMLS CUI [1])
Antidepressive Agents
Item
use of antidepressants within 1 month of the study
boolean
C0003289 (UMLS CUI [1])
Kidney Diseases | Liver diseases
Item
renal or hepatic disorder
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Upper gastrointestinal hemorrhage
Item
patients with upper gi bleeds
boolean
C0041909 (UMLS CUI [1])
Inappropriate ADH Syndrome
Item
patients with siadh syndrome
boolean
C0021141 (UMLS CUI [1])
Pregnancy
Item
pregnant woman
boolean
C0032961 (UMLS CUI [1])
Criteria Cessation Clinical Trial
Item
criteria for the cessation of the study after initial commencement:
boolean
C0243161 (UMLS CUI [1,1])
C1880019 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Adverse events Severe | Adverse events Gastrointestinal Severe | Adverse events Cardiovascular Severe | Adverse events Neurologic Severe | Adverse events Hematologic Severe | Adverse events Urologic Severe
Item
severe adverse events (including but not only gi, cardiovascular, neurologic, hematologic or urologic severe adverse events)
boolean
C0877248 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0521362 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0877248 (UMLS CUI [3,1])
C3887460 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0877248 (UMLS CUI [4,1])
C0205494 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0877248 (UMLS CUI [5,1])
C0205488 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
C0877248 (UMLS CUI [6,1])
C0042077 (UMLS CUI [6,2])
C0205082 (UMLS CUI [6,3])
Emergency Suicidality
Item
emergent suicidality
boolean
C2745965 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
Emergency Symptoms Hypomania | Emergency Manic symptom
Item
emergence of hypomanic or manic symptoms
boolean
C2745965 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0241934 (UMLS CUI [1,3])
C2745965 (UMLS CUI [2,1])
C0746402 (UMLS CUI [2,2])
Cessation Requested by patient
Item
if the subject requests to stop
boolean
C1880019 (UMLS CUI [1,1])
C0332153 (UMLS CUI [1,2])
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