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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02793648 |
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Date of registration:
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30/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.
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Scientific title:
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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 |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02793648 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Lucia M Perez-Costillas, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Regional universitario de Malaga. UGC Salud Mental. |
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Key inclusion & exclusion criteria
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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)
Age minimum:
55 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Drug: Alpha tocopherol
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Drug: Ascorbic Acid
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Drug: PLACEBO
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Primary Outcome(s)
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Change in depressive symptoms through Beck Depression Inventory (BDI)
[Time Frame: 0,3, 6 months]
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Secondary Outcome(s)
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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]
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Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE)
[Time Frame: 0,3, 6 months]
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Change in the disease through the Clinical Global Impression (CGI)
[Time Frame: 0,3, 6 months]
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Change in the levels of blood oxidative stress through the antioxidant level
[Time Frame: 0,3, 6 months]
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Change in anxiety through the State Anxiety Inventory (STAI-S)
[Time Frame: 0, 3, 6 months]
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Change in the memory through the Wechsler Memory Scale (WMS-III)
[Time Frame: 0, 3, 6 months]
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Secondary ID(s)
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PI-0290-2012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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