DepressionPhase 4NCT03384329
Efficacy of Resveratrol in Depression
A Phase 4 study testing Resveratrol Pill in people with Depression, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Resveratrol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 4 Jul 2018to 18 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
- current depression.
Who cannot join
- serious or unstable disease;
- antidepressants intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after the intervention, and in 2 week follow up).
- Conditions
- Depression
- Being tested
- Resveratrol Pill, Placebos
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol PillDrug
Resveratrol 500 mg
PlacebosDrug
Placebo Pills
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol Pill | Experimental | Not described Receives: Drug: Resveratrol Pill |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total HDRS-17 Score From Baseline to Week 4
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Measured: 4 weeks
Change in SIRT1 Activity From Baseline to Week 4
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood
Measured: 4 weeks
Secondary outcomes (1)
Change in Total BDI-II Score From Baseline to Week 4
Beck Depression Inventory 21 items, total score range 0-63 (63 - worse)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start4 Jul 2018
- Primary completion27 Aug 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Russian Science Foundation
- Responsible party
- Principal investigator, Lyubomir I Aftanas, MD, PhD, DrSci., Prof., Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384329
- Sponsor's protocol ID
- RESV-depression
- Status last verified
- Nov 2020
- First submitted
- 11 Dec 2017
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
- ClinicalTrials.gov ID
- NCT03384329
- Acronym / sponsor ID
- RESV-depression
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Russian Science Foundation
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after the intervention, and in 2 week follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol Pill | Experimental | Drug: Resveratrol Pill |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
- current depression.
Key exclusion criteria (2 listed)
- serious or unstable disease;
- antidepressants intake.
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 |
|---|---|---|
| Resveratrol PillResveratrol 500 mg | Drug | Resveratrol Pill |
| PlacebosPlacebo Pills | Drug | Placebo |
Primary outcome
Change in Total HDRS-17 Score From Baseline to Week 4
Time frame: 4 weeks
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Change in SIRT1 Activity From Baseline to Week 4
Time frame: 4 weeks
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood
1 secondary outcome
Change in Total BDI-II Score From Baseline to Week 4
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resveratrol Pill in people with Depression, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 2 inclusion and 2 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 8 Dec 2020. 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 Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Total HDRS-17 Score From Baseline to Week 4 (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 8 Dec 2020.