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Predictors of the Outcome of Late Life Depression

NCT02441387 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2018-05-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Antidepressant

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.

OTHER

Psychoeducation

Patients who are in the antidepressant treatment group and does not reach remission (MADRS score \<or =8) until visit 4 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 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.

OTHER

Treatment as usual (only pharmacological treatment).

Patients who are in the antidepressant treatment group and does not reach remission (MADRS score \<or =8) until visit 4 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).

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Cassio MC Bottino, phD · Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

  • Salma Rose Imanari Ribeiz, phD · Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-03-31
Completion
2019-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02441387 on ClinicalTrials.gov