Clinical trial NCT02441387: Predictors of the Outcome of Late Life Depression
Official title: Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depression
Keywords: depression
elderly
remission
treatment response
predictors of response
cognitive decline
structural neuroimage
genetic polymorphism
psychoeducation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are 60 years old or older with Major Depression (DSMIV-TR).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Change from baseline Clinical Global Impression (CGI) up to 18 months
timeFrame: 18 months
measure: Change from baseline Hamilton-D Scale (HAM-D) up to 18 months
timeFrame: 18 months
measure: Change from baseline Mini Mental State Examination (MMSE) up to 18 months
timeFrame: 18 months
measure: Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months
timeFrame: 18 months
measure: Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
Study officials:
affiliation: Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
name: Cassio MC Bottino, phD
role: STUDY_DIRECTOR
affiliation: Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
name: Salma Rose Imanari Ribeiz, phD
role: PRINCIPAL_INVESTIGATOR
References: