Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

NCT ID: NCT02793648

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-01-31

Brief 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).

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks

Group Type: EXPERIMENTAL

Ascorbic Acid

Intervention Type: DRUG

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

Alpha tocopherol

Intervention Type: DRUG

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

Placebo

colloidal Silica 200mg twice a day for twelve weeks

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

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

Interventions

Ascorbic Acid

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

Intervention Type: DRUG

Alpha tocopherol

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

Intervention Type: DRUG

PLACEBO

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

Intervention Type: DRUG

Other Intervention Names

Vitamin C; Vitamin E; colloidal silica

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yolanda de Diego Otero

OTHER

Sponsor Role: lead

Responsible Party

Yolanda de Diego Otero

MSc. PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lucia M Perez-Costillas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional universitario de Malaga. UGC Salud Mental.

Locations

Psychiatric Service. Hospital Regional Universitario

Málaga, , Spain

Countries

Spain

Other Identifiers

PI-0290-2012

Identifier Type: -

Identifier Source: org_study_id