Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

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

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).

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Ascorbic Acid; Drug: Alpha tocopherol; Drug: PLACEBO

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Malaga, Spain, 29009
    • Psychiatric Service. Hospital Regional Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks	Drug: Ascorbic Acid; Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner; Other Names: Vitamin C; Drug: Alpha tocopherol; Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner; Other Names: Vitamin E
Placebo Comparator: Placebo; colloidal Silica 200mg twice a day for twelve weeks	Drug: PLACEBO; Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner; Other Names: colloidal silica

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in anxiety through the State Anxiety Inventory (STAI-S)	0, 3, 6 months
Change in the memory through the Wechsler Memory Scale (WMS-III)	0, 3, 6 months
Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE)	0,3, 6 months
Change in the disease through the Clinical Global Impression (CGI)	0,3, 6 months
Change in the individual level of functioning through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	0,3, 6 months
Change in the levels of blood oxidative stress through the antioxidant level	0,3, 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability analyzing the registered side effects	0,3, 6 months

Collaborators and Investigators

• Sponsor: Yolanda de Diego Otero
• Investigators: Principal Investigator: Lucia M Perez-Costillas, MD PhD, Hospital Regional universitario de Malaga. UGC Salud Mental.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Elderly
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Ascorbic Acid
• Other Study ID Numbers: PI-0290-2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No