Predictors of the Outcome of Late Life Depression

Major Depression Clinical Trial

Official title:

Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02441387
• Other study ID #: PREDLLD10446
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: July 2019

Study information

• Verified date: May 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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.
• 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).

Locations

Country	Name	City	State
Brazil	University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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