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- Ensaio Clínico NCT01491412
Non-interventional Study: Real-life Use of Atypical Antipsychotics in Acute Inpatient Management of Schizophrenia
RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia
This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.
In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.
The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Budapest, Hungria
- Research Site
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Debrecen, Hungria
- Research Site
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Gyor, Hungria
- Research Site
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Kerepestarcsa, Hungria
- Research Site
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Nyiregyhaza, Hungria
- Research Site
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Szekesfehervar, Hungria
- Research Site
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Szekszard, Hungria
- Research Site
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Daugavpils, Letônia
- Research Site
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Jelgava, Letônia
- Research Site
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Liepaja, Letônia
- Research Site
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Riga, Letônia
- Research Site
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Strenci, Letônia
- Research Site
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Bucharest, Romênia
- Research Site
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Iasi, Romênia
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).
- Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- Subject is hospitalised due to an acute psychotic episode
Exclusion Criteria:
- Current participation in any clinical trial.
- Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Acute psychotic episode in schizophrenia
Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Description of used atypical antipsychotic(s) during hospitalisation
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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The data will be collected at one visit at the moment of discharge from the hospital.
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of the daily dosage of atypical antipsychotic(s) during hospitalisation
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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The data will be collected at one visit at the moment of discharge from the hospital.
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of mode of administration of atypical antipsychotic(s) during hospitalisation
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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The data will be collected at one visit at the moment of discharge from the hospital.
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Percent of patients with atypical antipsychotic as monotherapy
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Percent of patients with combinations of antipsychotics.
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of main criteria used for selection of an antipsychotic during hospitalisation.
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.
Prazo: hospitalisation period, an expected average of 2 weeks (variable per patient)
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hospitalisation period, an expected average of 2 weeks (variable per patient)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Radu TEODORESCU, Prof., Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NIS-NME-SER-2011/1
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