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Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

NCT02793648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-03-01

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Ascorbic Acid

Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner

DRUG

Alpha tocopherol

Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner

DRUG

PLACEBO

Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner

Sponsors & Collaborators

  • Yolanda de Diego Otero

    lead OTHER

Principal Investigators

  • Lucia M Perez-Costillas, MD PhD · Hospital Regional universitario de Malaga. UGC Salud Mental.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-11-30
Completion
2018-01-31

Countries

  • Spain

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793648 on ClinicalTrials.gov