ID

32255

Beschrijving

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

Trefwoorden

  1. 24-10-18 24-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 oktober 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Schizophrenia NCT01300364

Eligibility Schizophrenia NCT01300364

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Schizophrenia

Datatype

boolean

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

Antipsychotic Agents Dose Stable | olanzapine | Risperidone

Datatype

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)
Beschrijving

Symptoms Negative | PANSS Symptoms Negative

Datatype

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
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Substance Use Disorders | Substance Dependence

Datatype

boolean

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

Mental Retardation

Datatype

boolean

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

Antidepressive Agents

Datatype

boolean

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

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

Datatype

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.
Beschrijving

Hamilton rating scale for depression

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Renal Insufficiency Serious

Datatype

boolean

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

Hemorrhagic Disorders

Datatype

boolean

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

Hypersensitivity reboxetine | Citalopram allergy

Datatype

boolean

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

Similar models

Eligibility Schizophrenia NCT01300364

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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