Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Ascorbic Acid; Alpha tocopherol; PLACEBO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Vitamin C; Vitamin E; colloidal silica
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin E; Tocopherols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Elderly