ID

14384

Descrição

Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01668797

Link

https://clinicaltrials.gov/show/NCT01668797

Palavras-chave

  1. 12/04/2016 12/04/2016 -
Transferido a

12 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Acute Schizophrenia NCT01668797

Eligibility Acute Schizophrenia NCT01668797

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subjects with a current diagnosis of schizophrenia, as defined by dsm-iv-tr criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
Descrição

schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
Descrição

Maintains living environment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0517405
subjects who showed previous response to antipsychotic treatment in the past year.
Descrição

antipsychotic treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0748066
subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
Descrição

depot antipsychotics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2585377
subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
Descrição

Psychotic symptom

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871189
subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
Descrição

Disease Exacerbation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235874
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
Descrição

Urine pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0430059
patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
Descrição

Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current dsm-iv-tr axis ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Descrição

Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
subjects experiencing acute depressive symptoms within the past 30 days
Descrição

Depressive Symptoms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086132
subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
Descrição

Unresponsive to Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205269
subjects with a significant risk of violent behavior; who represent a risk of committing suicide
Descrição

Aggressive behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001807
subjects with clinically significant tardive dyskinesia
Descrição

Tardive Dyskinesia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686347
subjects currently treated with insulin for diabetes.
Descrição

insulin treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745343

Similar models

Eligibility Acute Schizophrenia NCT01668797

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
boolean
C0001779 (UMLS CUI [1])
schizophrenia
Item
subjects with a current diagnosis of schizophrenia, as defined by dsm-iv-tr criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
boolean
C0036341 (UMLS CUI [1])
Maintains living environment
Item
subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
boolean
C0517405 (UMLS CUI [1])
antipsychotic treatment
Item
subjects who showed previous response to antipsychotic treatment in the past year.
boolean
C0748066 (UMLS CUI [1])
depot antipsychotics
Item
subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
boolean
C2585377 (UMLS CUI [1])
Psychotic symptom
Item
subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
boolean
C0871189 (UMLS CUI [1])
Disease Exacerbation
Item
subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
boolean
C0235874 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Urine pregnancy test positive
Item
female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
boolean
C0430059 (UMLS CUI [1])
Schizophrenia
Item
patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
boolean
C0036341 (UMLS CUI [1])
Mental disorders
Item
patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current dsm-iv-tr axis ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
boolean
C0004936 (UMLS CUI [1])
Depressive Symptoms
Item
subjects experiencing acute depressive symptoms within the past 30 days
boolean
C0086132 (UMLS CUI [1])
Unresponsive to Treatment
Item
subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
boolean
C0205269 (UMLS CUI [1])
Aggressive behavior
Item
subjects with a significant risk of violent behavior; who represent a risk of committing suicide
boolean
C0001807 (UMLS CUI [1])
Tardive Dyskinesia
Item
subjects with clinically significant tardive dyskinesia
boolean
C0686347 (UMLS CUI [1])
insulin treatment
Item
subjects currently treated with insulin for diabetes.
boolean
C0745343 (UMLS CUI [1])

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