Predictors of the Outcome of Late Life Depression
Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The relevance of depression prevention and treatment in older people tend to raise in future years, considering the rapid increase of the elderly population in Brazil and the growing impact of depression (the third cause of global burden of diseases in the world according to the World Health Association 2004 report). The association between structural brain changes and treatment response in patients with late-life depression (LLD) remains an intriguing area of research. Predictors of response to pharmacological treatment of major depressive disorder will be investigated in 120 elderly patients, who will be included in a naturalistic clinical trial, that will evaluate psychopathology, personality traits, cognitive performance, brain structural changes and genetic polymorphisms. Patients will be followed for 18 months with a treatment algorithm for depression and will be evaluated monthly until 6th month and every 3 months, up to 18 months, to assess factors associated to response to treatment.
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score <or =8) until 3 months of pharmacological treatment will be invited to be part of a psychoeducation program. If the patient accepts the psychoeducation intervention, he will be randomized to psychoeducation (pharmacological treatment plus psychoeducation) or treatment as usual (only pharmacological treatment). The psychoeducation program consists of 10 individual weekly sessions, conducted by a trained psychologist who will explain the main concepts of depression and its symptoms, the importance of adhering to treatment, the main side effects of pharmacological treatment, and how to cope with daily difficulties.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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São Paulo, Brasil, 05403-010
- University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
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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:
- 60 years old
- Major depression (DSMIV-TR)
- Evaluated with MINI
- Willing to participate.
Exclusion Criteria:
- Less than 60 years old
- Dementia syndrome
- Delirium or other organic mental disorders
- Alcohol/drug dependence
- Anxiety disorders, or other psychiatric disorders, and not willing (or not able) to participate
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Antidepressant treatment
According to their previous treatment history and clinical presentation, patients may take: Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year. |
Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year.
Outros nomes:
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score |
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Antidepressant treatment & Psychoeducation intervention
Antidepressant treatment and psych education program (10 weekly sessions).
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Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year.
Outros nomes:
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Montgomery-Asberg Depression Scale (MADRS) below 8 during the initial 12 weeks of the study and remained below 8 until 18 months
Prazo: 18 months
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The investigators will consider patients remitted when their MADRS scale score decreased below 8 during the initial 12 weeks of the study and remained below 8 until 24 weeks.
All patients whose MADRS scores decreased to 8 but rose above 8 during the study or whose MADRS score remained at 8 or above throughout the study were considered not remitted
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18 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline Clinical Global Impression (CGI) up to 18 months
Prazo: 18 months
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It will be applied on 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th, 15th, and 18th months of follow-up. On the 6th, 12th, and 18th months, the Mini Mental State Examination (MMSE), the Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG)and the Bayer Activities of Daily Living Scale (B-ADL) will be applied. |
18 months
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Change from baseline Hamilton-D Scale (HAM-D) up to 18 months
Prazo: 18 months
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It will be applied on 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th, 15th, and 18th months of follow-up. On the 6th, 12th, and 18th months, MMSE, the CAMCOG and the B-ADL will be applied. |
18 months
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Change from baseline Mini Mental State Examination (MMSE) up to 18 months
Prazo: 18 months
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It will be applied on 1st, 12th, and 18th months of follow-up.
On the 6th, 12th, and 18th months, MMSE, the CAMCOG and the B-ADL will be applied.
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18 months
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Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months
Prazo: 18 months
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It will be applied on 1st, 12th, and 18th months of follow-up.
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18 months
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Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months
Prazo: 18 months
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It will be applied on 1st, 12th, and 18th months of follow-up.
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18 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Cassio MC Bottino, phD, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
- Investigador principal: Salma Rose Imanari Ribeiz, phD, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
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 (Real)
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
- PREDLLD10446
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