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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 treatment & Psychoeducation intervention | Antidepressant treatment and psych education program (10 weekly sessions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidepressant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are 60 years old or older with Major Depression (DSMIV-TR).
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| Name | Affiliation | Role |
|---|---|---|
| Cassio MC Bottino, phD | Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine | Study Director |
| Salma Rose Imanari Ribeiz, phD | Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry | São Paulo | 05403-010 | Brazil |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| D020280 | Sertraline |
| D000089983 | Escitalopram |
| D000069470 | Venlafaxine Hydrochloride |
| D000078785 | Mirtazapine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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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).
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| Psychoeducation | Other | Patients who are in the antidepressant treatment group and does not reach remission (MADRS score \ |
|
| Treatment as usual (only pharmacological treatment). | Other | Patients who are in the antidepressant treatment group and does not reach remission (MADRS score \ |
|
| 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. | 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. | 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. | 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. | 18 months |
| D001519 |
| Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D020164 | Chemical Actions and Uses |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D008055 | Lipids |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |