ID

32255

Description

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

Keywords

  1. 10/24/18 10/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 24, 2018

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.

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 NCT01300364

Eligibility Schizophrenia NCT01300364

Inclusion Criteria
Description

Inclusion Criteria

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

Schizophrenia

Data type

boolean

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

Antipsychotic Agents Dose Stable | olanzapine | Risperidone

Data type

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)
Description

Symptoms Negative | PANSS Symptoms Negative

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Substance Use Disorders | Substance Dependence

Data type

boolean

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

Mental Retardation

Data type

boolean

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

Antidepressive Agents

Data type

boolean

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

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

Data type

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.
Description

Hamilton rating scale for depression

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Renal Insufficiency Serious

Data type

boolean

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

Hemorrhagic Disorders

Data type

boolean

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

Hypersensitivity reboxetine | Citalopram allergy

Data type

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)
Data type
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])

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

Fields marked with * are required.

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