ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictors of the Outcome of Late Life Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02441387
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment
Major Depression Drug: Antidepressant Other: Psychoeducation Other: Treatment as usual (only pharmacological treatment).

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 [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression
Actual Study Start Date : April 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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 Name: 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 <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 & 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 Name: zoloft, lexapro, efexor, remeron, carbolithium

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.




Primary Outcome Measures :
  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 [ Time Frame: 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


Secondary Outcome Measures :
  1. Change from baseline Clinical Global Impression (CGI) up to 18 months [ Time Frame: 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.


  2. Change from baseline Hamilton-D Scale (HAM-D) up to 18 months [ Time Frame: 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.


  3. Change from baseline Mini Mental State Examination (MMSE) up to 18 months [ Time Frame: 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.

  4. Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months [ Time Frame: 18 months ]
    It will be applied on 1st, 12th, and 18th months of follow-up.

  5. Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months [ Time Frame: 18 months ]
    It will be applied on 1st, 12th, and 18th months of follow-up.


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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are 60 years old or older with Major Depression (DSMIV-TR).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441387


Locations
Brazil
University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
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

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02441387     History of Changes
Other Study ID Numbers: PREDLLD10446
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Sao Paulo General Hospital:
depression
elderly
remission
treatment response
predictors of response
cognitive decline
structural neuroimage
genetic polymorphism
psychoeducation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs