Predictors of the Outcome of Late Life Depression
- Conditions
- Major Depression
- Interventions
- Other: Treatment as usual (only pharmacological treatment).Other: Psychoeducation
- Registration Number
- NCT02441387
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
Predictors of response to pharmacological treatment of major depressive disorder will be investigated. One hundred and twenty patients will be included in a naturalistic clinical trial. Psychopathology, personality traits, cognitive performance, brain structural changes and genetic polymorphisms will be evaluated. Patients will be followed for 18 months with a pharmacological treatment algorithm and will be evaluated monthly until 6th month and every 3 months, up to 18 months. Psychoeducation will be offered to patients who did not remit until 3 months of pharmacological tretment.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 60 years old
- Major depression (DSMIV-TR)
- Evaluated with MINI
- Willing to participate.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Antidepressant treatment Antidepressant 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. Antidepressant treatment & Psychoeducation intervention Antidepressant Antidepressant treatment and psych education program (10 weekly sessions). Antidepressant treatment Treatment as usual (only pharmacological 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. Antidepressant treatment & Psychoeducation intervention Psychoeducation Antidepressant treatment and psych education program (10 weekly sessions).
- Primary Outcome Measures
Name Time Method 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 18 months 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
- Secondary Outcome Measures
Name Time Method Change from baseline Mini Mental State Examination (MMSE) up to 18 months 18 months 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.
Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months 18 months It will be applied on 1st, 12th, and 18th months of follow-up.
Change from baseline Hamilton-D Scale (HAM-D) up to 18 months 18 months 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.Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months 18 months It will be applied on 1st, 12th, and 18th months of follow-up.
Change from baseline Clinical Global Impression (CGI) up to 18 months 18 months 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.
Trial Locations
- Locations (1)
University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
🇧🇷São Paulo, Brazil