ID

32255

Descripción

Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01300364

Link

https://clinicaltrials.gov/show/NCT01300364

Palabras clave

Versiones (1)
  1. 24/10/18 24/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01300364

Inglés

Eligibility Schizophrenia NCT01300364

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of schizophrenia (dsm-iv criteria)
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
Descripción

Antipsychotic Agents Dose Stable | olanzapine | Risperidone

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0171023
UMLS CUI [3]
C0073393
presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the panss scale) (kay 1987)
Descripción

Symptoms Negative | PANSS Symptoms Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C4086747
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1513916
patients have to give written informed consent to participate in the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a substance abuse/dependence diagnosis in the previous six months.
Descripción

Substance Use Disorders | Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
mental retardation.
Descripción

Mental Retardation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025362
patients taking antidepressant in the last 4 months before the trial.
Descripción

Antidepressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003289
patients taking other antipsychotic medication, except: sinquan 100, entumine 40, largactil 100 and seroquel 200.
Descripción

Antipsychotic Agents Other | Exception Sinequan | Exception Entumine | Exception Largactil | Exception Seroquel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0728757
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0950873
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600062
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0287163
patients who score more than 20 in hamilton rating scale for depression.
Descripción

Hamilton rating scale for depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451203
pregnancy or lactation.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious impaired kidney function.
Descripción

Renal Insufficiency Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205404
history of hemorrhagic disorders.
Descripción

Hemorrhagic Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019087
reboxetine or citalopram allergy.
Descripción

Hypersensitivity reboxetine | Citalopram allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0168388
UMLS CUI [2]
C0570769
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Similar models

Eligibility Schizophrenia NCT01300364

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
diagnosis of schizophrenia (dsm-iv criteria)
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agents Dose Stable | olanzapine | Risperidone
Item
stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0171023 (UMLS CUI [2])
C0073393 (UMLS CUI [3])
Symptoms Negative | PANSS Symptoms Negative
Item
presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the panss scale) (kay 1987)
boolean
C1457887 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C4086747 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Informed Consent
Item
patients have to give written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Substance Dependence
Item
patients with a substance abuse/dependence diagnosis in the previous six months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Mental Retardation
Item
mental retardation.
boolean
C0025362 (UMLS CUI [1])
Antidepressive Agents
Item
patients taking antidepressant in the last 4 months before the trial.
boolean
C0003289 (UMLS CUI [1])
Antipsychotic Agents Other | Exception Sinequan | Exception Entumine | Exception Largactil | Exception Seroquel
Item
patients taking other antipsychotic medication, except: sinquan 100, entumine 40, largactil 100 and seroquel 200.
boolean
C0040615 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0728757 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0950873 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600062 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0287163 (UMLS CUI [5,2])
Hamilton rating scale for depression
Item
patients who score more than 20 in hamilton rating scale for depression.
boolean
C0451203 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Renal Insufficiency Serious
Item
serious impaired kidney function.
boolean
C1565489 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Hemorrhagic Disorders
Item
history of hemorrhagic disorders.
boolean
C0019087 (UMLS CUI [1])
Hypersensitivity reboxetine | Citalopram allergy
Item
reboxetine or citalopram allergy.
boolean
C0020517 (UMLS CUI [1,1])
C0168388 (UMLS CUI [1,2])
C0570769 (UMLS CUI [2])
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