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Predictors of the Outcome of Late Life Depression

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Major Depression

Treatments

Drug: Antidepressant
Other: Treatment as usual (only pharmacological treatment).
Other: Psychoeducation

Study type

Observational

Funder types

Other

Identifiers

NCT02441387
PREDLLD10446

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Antidepressant treatment
Description:
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.
Treatment:
Other: Treatment as usual (only pharmacological treatment).
Drug: Antidepressant
Antidepressant treatment & Psychoeducation intervention
Description:
Antidepressant treatment and psych education program (10 weekly sessions).
Treatment:
Other: Psychoeducation
Drug: Antidepressant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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