Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

Overview

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).

Full Title of Study: “Phase II, Double-blind, Randomized, 1-way Cross-over, to Investigate the Effectiveness of the Combination of Ascorbic Acid (Vitamin C) and Tocopherol (Vitamin E) Versus Placebo for the Treatment of Depressive Disorders in Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2017

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.

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

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks
  • Placebo Comparator: Placebo
    • colloidal Silica 200mg twice a day for twelve weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in depressive symptoms through Beck Depression Inventory (BDI)
    • Time Frame: 0,3, 6 months

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of mild or moderate depression by Mini International Neuropsychiatric Interview (MINI).
  • Having more than 55 years old
  • Have signed the informed consent document before starting the participation in the trial

Exclusion Criteria

  • Any advanced severe or unstable disease.
  • Previous diagnose and / or presence of severe mental disorder.
  • Risk of suicidal behavior.
  • Any treatment regimen, including treatment with psychotropic drugs and / or anticonvulsant therapy that has not been stable for a period ≥ 4 weeks prior to randomization.
  • Current treatment with more than two psychoactive medications, including medications for seizures control.
  • Intake more than 100 mg of vitamin E or C a day in the last 4 months.
  • Hypoprothrombinemia secondary to vitamin K deficiency
  • Glucose 6-phosphate dehydrogenase deficiency (G-6-PD).
  • Treatment with oral anticoagulants.
  • Initiate or change the pharmacological or non-pharmacological interventions during the course of the trial.
  • Allergy to the formula components (or excipient used)

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yolanda de Diego Otero
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yolanda de Diego Otero, MSc. PhD – The Mediterranean Institute for the Advance of Biotechnology and Health Research
  • Overall Official(s)
    • Lucia M Perez-Costillas, MD PhD, Principal Investigator, Hospital Regional universitario de Malaga. UGC Salud Mental.

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