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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in depressive symptoms through Beck Depression Inventory (BDI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Placebo
colloidal Silica 200mg twice a day for twelve weeks
Intervention: PLACEBO (Drug)
Treatment
Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks
Intervention: Alpha tocopherol (Drug)
Treatment
Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks
Intervention: Ascorbic Acid (Drug)
Outcomes
Primary Outcomes
Change in depressive symptoms through Beck Depression Inventory (BDI)
Time Frame: 0,3, 6 months
Secondary Outcomes
- 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)
Investigators
Yolanda de Diego Otero
MSc. PhD
The Mediterranean Institute for the Advance of Biotechnology and Health Research