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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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São Paulo, Brazílie, 05403-010
- University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
Ostatní jména:
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.
Ostatní jména:
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline Clinical Global Impression (CGI) up to 18 months
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Cassio MC Bottino, phD, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
- Vrchní vyšetřovatel: Salma Rose Imanari Ribeiz, phD, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PREDLLD10446
Plán pro data jednotlivých účastníků (IPD)
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