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Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ascorbic Acid
Alpha tocopherol
PLACEBO
Sponsored by
Yolanda de Diego Otero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Elderly

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Psychiatric Service. Hospital Regional Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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

colloidal Silica 200mg twice a day for twelve weeks

Outcomes

Primary Outcome Measures

Change in depressive symptoms through Beck Depression Inventory (BDI)

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2015
Last Updated
February 27, 2018
Sponsor
Yolanda de Diego Otero
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1. Study Identification

Unique Protocol Identification Number
NCT02793648
Brief Title
Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yolanda de Diego Otero

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
colloidal Silica 200mg twice a day for twelve weeks
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C
Intervention Description
Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner
Intervention Type
Drug
Intervention Name(s)
Alpha tocopherol
Other Intervention Name(s)
Vitamin E
Intervention Description
Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
colloidal silica
Intervention Description
Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner
Primary Outcome Measure Information:
Title
Change in depressive symptoms through Beck Depression Inventory (BDI)
Time Frame
0,3, 6 months
Secondary Outcome Measure Information:
Title
Change in anxiety through the State Anxiety Inventory (STAI-S)
Time Frame
0, 3, 6 months
Title
Change in the memory through the Wechsler Memory Scale (WMS-III)
Time Frame
0, 3, 6 months
Title
Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE)
Time Frame
0,3, 6 months
Title
Change in the disease through the Clinical Global Impression (CGI)
Time Frame
0,3, 6 months
Title
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
Title
Change in the levels of blood oxidative stress through the antioxidant level
Time Frame
0,3, 6 months
Other Pre-specified Outcome Measures:
Title
Safety and tolerability analyzing the registered side effects
Time Frame
0,3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia M Perez-Costillas, MD PhD
Organizational Affiliation
Hospital Regional universitario de Malaga. UGC Salud Mental.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Service. Hospital Regional Universitario
City
Malaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.

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