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. * Design: Pilot clinical trial, Phase II , 6-month randomized, double-blind placebo-controlled one-way crossover clinical trial, with two treatment periods of 12 weeks duration. * Setting: Regional University Hospital, Malaga. * Subjects: people older tan 55 years diagnosed with depression. * Intervention: 50 participants randomly assigned, to receive antioxidant vitamins C (ascorbic acid) and vitamin E (d-alpha-tocopherol) once a day or placebo for 12 weeks double-blind. In Study Period 2, all participants receive (open) active treatment. Outcome measures: improvement in depressive symptoms. Plasma antioxidant status, also memory will be assessed by Wechsler Memory Scale (WMS-III), and cognitive improvement will be analyzed using Mini mental state examination (MMSE) at 0, 3, 6 months during the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner
Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner
Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner
Psychiatric Service. Hospital Regional Universitario
Málaga, Spain
Change in depressive symptoms through Beck Depression Inventory (BDI)
Time frame: 0,3, 6 months
Change in anxiety through the State Anxiety Inventory (STAI-S)
Time frame: 0, 3, 6 months
Change in the memory through the Wechsler Memory Scale (WMS-III)
Time frame: 0, 3, 6 months
Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE)
Time frame: 0,3, 6 months
Change in the disease through the Clinical Global Impression (CGI)
Time frame: 0,3, 6 months
Change in the individual level of functioning through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 0,3, 6 months
Change in the levels of blood oxidative stress through the antioxidant level
Time frame: 0,3, 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.