Skip to main content
OpenTrials
Completed

NCT Number: NCT02793648

Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psychiatric Service. Hospital Regional Universitario

Málaga, 29009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ascorbic acid

Drug

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

Other names: Vitamin C

Alpha tocopherol

Drug

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

Other names: Vitamin E

Placebo

Drug

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

Other names: colloidal silica

Primary outcomes

  1. Change in depressive symptoms through Beck Depression Inventory (BDI)

    Time frame: 0,3, 6 months

Secondary outcomes

  1. Change in anxiety through the State Anxiety Inventory (STAI-S)

    Time frame: 0, 3, 6 months

  2. Change in the memory through the Wechsler Memory Scale (WMS-III)

    Time frame: 0, 3, 6 months

  3. Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE)

    Time frame: 0,3, 6 months

  4. Change in the disease through the Clinical Global Impression (CGI)

    Time frame: 0,3, 6 months

  5. 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

  6. Change in the levels of blood oxidative stress through the antioxidant level

    Time frame: 0,3, 6 months

Other outcomes

  1. Safety and tolerability analyzing the registered side effects

    Time frame: 0,3, 6 months

Sponsors and collaborators

Lead sponsor

Yolanda de Diego Otero

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 8, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.