- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03384329
Efficacy of Resveratrol in Depression
November 17, 2020 updated by: Lyubomir I Aftanas, MD, PhD, DrSci., Prof., Russian Academy of Medical Sciences
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Novosibirsk, Russian Federation, 630117
- Lyubomir I. Aftanas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (selectively):
- MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
- current depression.
Exclusion Criteria (selectively):
- serious or unstable disease;
- antidepressants intake.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo Pills
|
Experimental: Resveratrol Pill
|
Resveratrol 500 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4 weeks
|
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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total BDI-II Score From Baseline to Week 4
Time Frame: 4 weeks
|
Beck Depression Inventory 21 items, total score range 0-63 (63 - worse)
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 4, 2018
Primary Completion (Actual)
August 27, 2019
Study Completion (Actual)
September 18, 2019
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 19, 2017
First Posted (Actual)
December 27, 2017
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
November 17, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESV-depression
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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