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Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

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ClinicalTrials.gov Identifier: NCT02793648
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Yolanda de Diego Otero, The Mediterranean Institute for the Advance of Biotechnology and Health Research

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).

Condition or disease Intervention/treatment Phase
Depression Drug: Ascorbic Acid Drug: Alpha tocopherol Drug: PLACEBO Phase 2

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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018


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 Name: Vitamin C

Drug: Alpha tocopherol
Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner
Other Name: 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 Name: colloidal silica




Primary Outcome Measures :
  1. Change in depressive symptoms through Beck Depression Inventory (BDI) [ Time Frame: 0,3, 6 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Safety and tolerability analyzing the registered side effects [ Time Frame: 0,3, 6 months ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793648


Locations
Spain
Psychiatric Service. Hospital Regional Universitario
Malaga, Spain, 29009
Sponsors and Collaborators
Yolanda de Diego Otero
Investigators
Principal Investigator: Lucia M Perez-Costillas, MD PhD Hospital Regional universitario de Malaga. UGC Salud Mental.

Responsible Party: Yolanda de Diego Otero, MSc. PhD, The Mediterranean Institute for the Advance of Biotechnology and Health Research
ClinicalTrials.gov Identifier: NCT02793648     History of Changes
Other Study ID Numbers: PI-0290-2012
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yolanda de Diego Otero, The Mediterranean Institute for the Advance of Biotechnology and Health Research:
Depression
Elderly

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents