DepressionPhase 2NCT02793648
Effectiveness of Ascorbic Acid and Tocopherol for Depression in Elderly.
A Phase 2 study testing Ascorbic Acid and Alpha tocopherol in people with Depression, run by Yolanda de Diego Otero at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Ascorbic Acid and Alpha tocopherol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Depression
- Being tested
- Ascorbic Acid, Alpha tocopherol, PLACEBO
- Keywords
- Depression, Elderly
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C
Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner
Alpha tocopherolDrug
Also called Vitamin E
Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner
PLACEBODrug
Also called colloidal silica
Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Ascorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks Receives: Drug: Ascorbic Acid; Drug: Alpha tocopherol |
| Placebo | Placebo comparator | colloidal Silica 200mg twice a day for twelve weeks Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms through Beck Depression Inventory (BDI)
Measured: 0,3, 6 months
Secondary outcomes (6)
Change in anxiety through the State Anxiety Inventory (STAI-S)
Measured: 0, 3, 6 months
Change in the memory through the Wechsler Memory Scale (WMS-III)
Measured: 0, 3, 6 months
Change in cognitive impairment through MINI MENTAL STATE EXAMINATION (MMSE)
Measured: 0,3, 6 months
Change in the disease through the Clinical Global Impression (CGI)
Measured: 0,3, 6 months
Change in the individual level of functioning through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Measured: 0,3, 6 months
Change in the levels of blood oxidative stress through the antioxidant level
Measured: 0,3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startOct 2014
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yolanda de Diego Otero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yolanda de Diego Otero, The Mediterranean Institute for the Advance of Biotechnology and Health Research
- Investigators
- Lucia M Perez-Costillas, MD PhD, Principal investigator, Hospital Regional universitario de Malaga. UGC Salud Mental.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793648
- Sponsor's protocol ID
- PI-0290-2012
- Status last verified
- Feb 2018
- First submitted
- 30 Nov 2015
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02793648
- Acronym / sponsor ID
- PI-0290-2012
- Conditions
- Depression
- Keywords
- Depression, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yolanda de Diego OteroUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ascorbic Acid, Drug: Alpha tocopherolAscorbic acid 200mg twice a day for twelve weeks Alpha tocopherol 200mg twice a day for twelve weeks |
| Placebo | Placebo comparator | Drug: PLACEBOcolloidal Silica 200mg twice a day for twelve weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin CTwo daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner | Drug | Treatment |
| Alpha tocopherolAlso: Vitamin ETwo daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner | Drug | Treatment |
| PLACEBOAlso: colloidal silicaTwo daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner | Drug | Placebo |
Primary outcome
Change in depressive symptoms through Beck Depression Inventory (BDI)
Time frame: 0,3, 6 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia M Perez-Costillas, MD PhD principal investigator
Hospital Regional universitario de Malaga. UGC Salud Mental.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid and Alpha tocopherol in people with Depression, run by Yolanda de Diego Otero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms through Beck Depression Inventory (BDI) (time frame: 0,3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.