ID

32304

Description

A Randomized, Double-blind, Comparison of the Efficacy and Safety of Amisulpride Versus Low-dose Amisulpride Plus Low-dose Sulpiride in the Treatment of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01615185

Link

https://clinicaltrials.gov/show/NCT01615185

Keywords

  1. 10/26/18 10/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 26, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT01615185

Eligibility Schizophrenia NCT01615185

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
cgi >=4
Description

Clinical global impression scale

Data type

boolean

Alias
UMLS CUI [1]
C3639708
washout of antipsychotics at least 3-5 days
Description

Washout Period Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0040615
written informed consents
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of serious adverse events to sulpiride or amisulpride
Description

Adverse event Serious Sulpiride | Adverse event Serious Amisulpride

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0038803
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0103045
history of neuroleptic malignant syndrome or tardive dyskinesia to antipsychotics
Description

Neuroleptic Malignant Syndrome | Tardive Dyskinesia | Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0686347
UMLS CUI [3]
C0040615
treatment-resistant schizophrenia
Description

Refractory schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C2063865
long-acting antipsychotics in the past 3 months
Description

Injection of depot antipsychotic agent

Data type

boolean

Alias
UMLS CUI [1]
C2585377
comorbid with substance abuse/dependence
Description

Comorbidity | Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0038580
female subjects with pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
severe physical illness
Description

Physical illness Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0205082

Similar models

Eligibility Schizophrenia NCT01615185

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
schizophrenia
boolean
C0036341 (UMLS CUI [1])
Clinical global impression scale
Item
cgi >=4
boolean
C3639708 (UMLS CUI [1])
Washout Period Antipsychotic Agents
Item
washout of antipsychotics at least 3-5 days
boolean
C1710661 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
Informed Consent
Item
written informed consents
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adverse event Serious Sulpiride | Adverse event Serious Amisulpride
Item
history of serious adverse events to sulpiride or amisulpride
boolean
C0877248 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0038803 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0103045 (UMLS CUI [2,3])
Neuroleptic Malignant Syndrome | Tardive Dyskinesia | Antipsychotic Agents
Item
history of neuroleptic malignant syndrome or tardive dyskinesia to antipsychotics
boolean
C0027849 (UMLS CUI [1])
C0686347 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
Refractory schizophrenia
Item
treatment-resistant schizophrenia
boolean
C2063865 (UMLS CUI [1])
Injection of depot antipsychotic agent
Item
long-acting antipsychotics in the past 3 months
boolean
C2585377 (UMLS CUI [1])
Comorbidity | Substance Use Disorders | Substance Dependence
Item
comorbid with substance abuse/dependence
boolean
C0009488 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
Pregnancy
Item
female subjects with pregnancy
boolean
C0032961 (UMLS CUI [1])
Physical illness Severe
Item
severe physical illness
boolean
C0683323 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

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