drugset / Trial / NCT02793648

Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

NCT02793648

Phase 2 Completed 50 enrolled Yolanda de Diego Otero
RandomizedCrossoverDouble-blindTreatment

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).

Timeline

Start
2014-10
Primary completion
2017-11
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 200 mg Oral
Subject alpha-tocopherol Unknown 200 mg Oral

Indications