Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
120 participants
OBSERVATIONAL
2015-04-30
2019-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder
NCT02286024
Magnetic Resonance Imaging Study of Geriatric Depression
NCT00245557
Determining Changes in Brain Structure Associated With Symptoms of Late-life Depression
NCT00178087
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
NCT01460212
DPA-714 and FDG PET/MRI in Depression
NCT06565936
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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).
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Major depression (DSMIV-TR)
* Evaluated with MINI
* Willing to participate.
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cassio MC Bottino, phD
Role: STUDY_DIRECTOR
Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Salma Rose Imanari Ribeiz, phD
Role: PRINCIPAL_INVESTIGATOR
Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PREDLLD10446
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.