Informações:
Falhas:
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
Versões (1)
- 12/04/2016 12/04/2016 -
Transferido a
12 de abril de 2016
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Acute Schizophrenia NCT01668797
Eligibility Acute Schizophrenia NCT01668797
- StudyEvent: Eligibility
Similar models
Eligibility Acute Schizophrenia NCT01668797
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])