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

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.

Study Overview

• Status: Unknown
• Conditions: Major Depression
• Intervention / Treatment: Drug: Antidepressant; Other: Treatment as usual (only pharmacological treatment).; Other: Psychoeducation

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-010
    • University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are 60 years old or older with Major Depression (DSMIV-TR).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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 Names: zoloft, lexapro, efexor, remeron, carbolithium; Other: Treatment as usual (only pharmacological treatment).; Patients who are in the antidepressant treatment group and does not reach remission (MADRS score
Antidepressant treatment & Psychoeducation intervention; Antidepressant treatment and psych education program (10 weekly sessions).	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 Names: zoloft, lexapro, efexor, remeron, carbolithium; Other: Psychoeducation; Patients who are in the antidepressant treatment group and does not reach remission (MADRS score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Clinical Global Impression (CGI) up to 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.	18 months
Change from baseline Hamilton-D Scale (HAM-D) up to 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.	18 months
Change from baseline Mini Mental State Examination (MMSE) up to 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.	18 months
Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months	It will be applied on 1st, 12th, and 18th months of follow-up.	18 months
Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months	It will be applied on 1st, 12th, and 18th months of follow-up.	18 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Cassio MC Bottino, phD, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine; Principal Investigator: Salma Rose Imanari Ribeiz, phD, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: depression; elderly; cognitive decline; remission; genetic polymorphism; psychoeducation; treatment response; predictors of response; structural neuroimage
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: PREDLLD10446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED