Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

NCT02793648 | Completed Phase 2 DMC

• 1 other identifier: PI-0290-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

Depression; Elderly

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms through Beck Depression Inventory (BDI)

  0,3, 6 months

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Safety and tolerability analyzing the registered side effects

  0,3, 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Ascorbic Acid; Drug: Alpha tocopherol

Placebo

PLACEBO COMPARATOR

colloidal Silica 200mg twice a day for twelve weeks

Drug: PLACEBO

Interventions

Ascorbic Acid DRUG

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

Also known as: Vitamin C

Treatment

Alpha tocopherol DRUG

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

Also known as: Vitamin E

Treatment

PLACEBO DRUG

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

Also known as: colloidal silica

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yolanda de Diego Otero: lead

Study Sites (1)

Psychiatric Service. Hospital Regional Universitario

Málaga, 29009, Spain

Location

MeSH Terms

Conditions

Depression

Interventions

Ascorbic Acid; alpha-Tocopherol; Vitamin E

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Tocopherols; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lucia M Perez-Costillas, MD PhD

  Hospital Regional universitario de Malaga. UGC Salud Mental.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc. PhD

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: June 8, 2016
• Study Start: October 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)