ID

25286

Description

An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00473434

Link

https://clinicaltrials.gov/show/NCT00473434

Keywords

Versions (1)
  1. 8/30/17 8/30/17 -
Uploaded on

August 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00473434

English

Eligibility Schizophrenia NCT00473434

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must satisfy the following criteria to be eligible for this study: patients with diagnoses of schizophrenia according to the dsm-iv criteria including newly diagnosed patients
Description

Schizophrenia | Patients Newly Diagnosed

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1518321
out-patients or in-patients with expected discharge within 8 weeks
Description

Outpatients | Inpatients Discharge Expected

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C0030685
UMLS CUI [2,3]
C1517001
patients or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Description

Informed Consent | Informed Consent Patient Representatives

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following criteria will be excluded from participating in the study: patients who are resistant to antipsychotic treatment
Description

Patients resistant to Antipsychotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C1319421
patients who have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months
Description

Clozapine | Antipsychotic Agents Injectable Long-term Active

Data type

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0086466
UMLS CUI [2,3]
C0443252
UMLS CUI [2,4]
C0205177
patients with cgl-s scores > 6 or who who have been hospitalized for longer than 8 continuous weeks during the past 6 months
Description

Clinical Global Impression Questionnaire | Hospital stay duration

Data type

boolean

Alias
UMLS CUI [1]
C3639708
UMLS CUI [2]
C4019086
pregnant or breast-feeding females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome.
Description

Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Tardive Dyskinesia Symptoms | Neuroleptic Malignant Syndrome Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2]
C0027849
UMLS CUI [3,1]
C0686347
UMLS CUI [3,2]
C1457887
UMLS CUI [4,1]
C0027849
UMLS CUI [4,2]
C1457887
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Similar models

Eligibility Schizophrenia NCT00473434

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Patients Newly Diagnosed
Item
patients must satisfy the following criteria to be eligible for this study: patients with diagnoses of schizophrenia according to the dsm-iv criteria including newly diagnosed patients
boolean
C0036341 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
Outpatients | Inpatients Discharge Expected
Item
out-patients or in-patients with expected discharge within 8 weeks
boolean
C0029921 (UMLS CUI [1])
C0021562 (UMLS CUI [2,1])
C0030685 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representatives
Item
patients or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patients resistant to Antipsychotic therapy
Item
patients who meet any of the following criteria will be excluded from participating in the study: patients who are resistant to antipsychotic treatment
boolean
C0030705 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C1319421 (UMLS CUI [1,3])
Clozapine | Antipsychotic Agents Injectable Long-term Active
Item
patients who have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months
boolean
C0009079 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C0205177 (UMLS CUI [2,4])
Clinical Global Impression Questionnaire | Hospital stay duration
Item
patients with cgl-s scores > 6 or who who have been hospitalized for longer than 8 continuous weeks during the past 6 months
boolean
C3639708 (UMLS CUI [1])
C4019086 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Tardive Dyskinesia Symptoms | Neuroleptic Malignant Syndrome Symptoms
Item
patients with a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome.
boolean
C0686347 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
C0686347 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0027849 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
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