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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Ascorbic Acid Drug: Alpha tocopherol Drug: PLACEBO||Phase 2|
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|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner
Other Name: colloidal silica
- Change in depressive symptoms through Beck Depression Inventory (BDI) [ Time Frame: 0,3, 6 months ]
- Change in anxiety through the State Anxiety Inventory (STAI-S) [ Time Frame: 0, 3, 6 months ]
- Change in the memory through the Wechsler Memory Scale (WMS-III) [ Time Frame: 0, 3, 6 months ]
- Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE) [ Time Frame: 0,3, 6 months ]
- Change in the disease through the Clinical Global Impression (CGI) [ Time Frame: 0,3, 6 months ]
- 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 ]
- Change in the levels of blood oxidative stress through the antioxidant level [ Time Frame: 0,3, 6 months ]
- Safety and tolerability analyzing the registered side effects [ Time Frame: 0,3, 6 months ]
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
|Psychiatric Service. Hospital Regional Universitario|
|Malaga, Spain, 29009|
|Principal Investigator:||Lucia M Perez-Costillas, MD PhD||Hospital Regional universitario de Malaga. UGC Salud Mental.|