Major DepressionNCT02441387
Predictors of the Outcome of Late Life Depression
An observational study of Major Depression, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Antidepressant, Psychoeducation and Treatment as usual (only pharmacological treatment).
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Jul 2019
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are 60 years old or older with Major Depression (DSMIV-TR).
Who may be able to join
- 60 years old
- Major depression (DSMIV-TR)
- Evaluated with MINI
- Willing to participate.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
São Paulo, 05403-010
About this study
Official title: Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression
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.
Read the 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.
- Conditions
- Major Depression
- Being tested
- Antidepressant, Psychoeducation, Treatment as usual (only pharmacological treatment).
- Keywords
- depression, elderly, remission, treatment response, predictors of response, cognitive decline, structural neuroimage, genetic polymorphism, psychoeducation
- Medical subject headings
- Depressive Disorder, Major, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
Also called zoloft, lexapro, efexor, remeron, carbolithium
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.
PsychoeducationOther
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).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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Antidepressant; Other: Treatment as usual (only pharmacological treatment). | |
| Antidepressant treatment & Psychoeducation intervention | Antidepressant treatment and psych education program (10 weekly sessions). Receives: Drug: Antidepressant; Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (5)
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 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
It will be applied on 1st, 12th, and 18th months of follow-up.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2018
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Cassio MC Bottino, phD, Study director, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of MedicineSalma Rose Imanari Ribeiz, phD, Principal investigator, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441387
- Sponsor's protocol ID
- PREDLLD10446
- Status last verified
- May 2018
- First submitted
- 10 Jul 2014
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression
- ClinicalTrials.gov ID
- NCT02441387
- Acronym / sponsor ID
- PREDLLD10446
- Conditions
- Major Depression
- Keywords
- depression, elderly, remission, treatment response, predictors of response, cognitive decline, structural neuroimage, genetic polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antidepressant treatment | – | Drug: Antidepressant, Other: Treatment as usual (only pharmacological 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 treatment & Psychoeducation intervention | – | Drug: Antidepressant, Other: PsychoeducationAntidepressant treatment and psych education program (10 weekly sessions). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are 60 years old or older with Major Depression (DSMIV-TR).
Key inclusion criteria (4 listed)
- 60 years old
- Major depression (DSMIV-TR)
- Evaluated with MINI
- Willing to participate.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidepressantAlso: zoloft, lexapro, efexor, remeron, carbolithiumSertraline 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 treatment, Antidepressant treatment & Psychoeducation intervention |
| PsychoeducationPatients 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. | Other | Antidepressant treatment & Psychoeducation intervention |
| 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 | Antidepressant treatment |
Primary outcome
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
5 secondary outcomes
Change from baseline Clinical Global Impression (CGI) up to 18 months
Time frame: 18 months
Change from baseline Hamilton-D Scale (HAM-D) up to 18 months
Time frame: 18 months
Change from baseline Mini Mental State Examination (MMSE) up to 18 months
Time frame: 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
Time frame: 18 months
Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassio MC Bottino, phD study director
Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Salma Rose Imanari Ribeiz, phD principal investigator
Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.