Predictors of the Outcome of Late Life Depression

NCT02441387 | Unknown DMC

• 1 other identifier: PREDLLD10446
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

depression; elderly; remission; treatment response; predictors of response; cognitive decline; structural neuroimage; genetic polymorphism; psychoeducation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline Clinical Global Impression (CGI) up to 18 months

  18 months

• Change from baseline Hamilton-D Scale (HAM-D) up to 18 months

  18 months

• Change from baseline Mini Mental State Examination (MMSE) up to 18 months

  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

  18 months

• Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months

  18 months

Study Arms (2)

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; Other: Treatment as usual (only pharmacological treatment).

Antidepressant treatment & Psychoeducation intervention

Antidepressant treatment and psych education program (10 weekly sessions).

Drug: Antidepressant; Other: Psychoeducation

Interventions

Antidepressant DRUG

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.

Also known as: zoloft, lexapro, efexor, remeron, carbolithium

Antidepressant treatment; Antidepressant treatment & Psychoeducation intervention

Psychoeducation OTHER

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.

Antidepressant treatment & Psychoeducation intervention

Treatment as usual (only pharmacological treatment). OTHER

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).

Antidepressant treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years old
• Major depression (DSMIV-TR)
• Evaluated with MINI
• Willing to participate.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry

São Paulo, 05403-010, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood (10mL) will be collected from participants, venocubital puncture into tubes with anticoagulant ethylenediamine tetraacetic acid (EDTA). After collection, the tubes will be properly stored at 4 ° C until the time of extraction. The genomic deoxyribonucleic acid (DNA) will be extracted using a salting out technique (Miller et al. 1988). After DNA extraction, the achieved concentration will be measured by reading the Gene Quant spectrophotometer (Pharmacia Biotech).

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Cognitive Dysfunction

Interventions

Antidepressive Agents; Sertraline; Escitalopram; Venlafaxine Hydrochloride; Mirtazapine; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Study Officials

• Cassio MC Bottino, phD

  Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

  STUDY DIRECTOR

• Salma Rose Imanari Ribeiz, phD

  Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: May 12, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2019
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

BR (1)