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The trial aims to treat depression. The incidence of major depression in the elderly accounts for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is studied. Besides depression in the elderly presents with cognitive impairment, impaired physical and social functioning, and predisposes to suicide. These are patients who often have multiple conditions and be taking numerous psychopharmacological treatments which hinders further treatment. The clinical trial will analyze the improvement in neuropsychiatric symptoms through different instruments The Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Life Events (AV), World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), Wechsler Memory Scale (WMS-III), Mini mental state examination (MMSE), Clinical Global Impression (CGI) and metabolic changes in the blood test measurements; after 12 weeks of antioxidant (Ascorbic acid and Tocopherol) treatment or placebo, and then after 24 weeks on active treatment with the antioxidant combination (Ascorbic acid and Tocopherol).
Objective: To evaluate the effect of the combination of the antioxidant Ascorbic acid and tocopherol, as therapy of the depressive disorder in the elderly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks |
|
| Placebo | Placebo Comparator | colloidal Silica 200mg twice a day for twelve weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms through Beck Depression Inventory (BDI) | 0,3, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety through the State Anxiety Inventory (STAI-S) | 0, 3, 6 months | |
| Change in the memory through the Wechsler Memory Scale (WMS-III) | 0, 3, 6 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability analyzing the registered side effects | 0,3, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia M Perez-Costillas, MD PhD | Hospital Regional universitario de Malaga. UGC Salud Mental. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Service. Hospital Regional Universitario | Málaga | 29009 | Spain |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D024502 | alpha-Tocopherol |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Alpha tocopherol | Drug | Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner |
|
|
| PLACEBO | Drug | Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner |
|
|
| Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE) |
| 0,3, 6 months |
| Change in the disease through the Clinical Global Impression (CGI) | 0,3, 6 months |
| Change in the individual level of functioning through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 0,3, 6 months |
| Change in the levels of blood oxidative stress through the antioxidant level | 0,3, 6 months |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D024505 | Tocopherols |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |