Efficacy of Resveratrol in Depression
Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
1 other identifier
interventional
30
1 country
1
Brief 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 the intervention, and in 2 week follow up).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 depression
Started Jul 2018
Shorter than P25 for phase_4 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2017
CompletedFirst Posted
Study publicly available on registry
December 27, 2017
CompletedStudy Start
First participant enrolled
July 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2019
CompletedResults Posted
Study results publicly available
November 17, 2020
CompletedDecember 8, 2020
November 1, 2020
1.1 years
December 11, 2017
October 23, 2020
November 17, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Total HDRS-17 Score From Baseline to Week 4
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
4 weeks
Change in SIRT1 Activity From Baseline to Week 4
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood
4 weeks
Secondary Outcomes (1)
Change in Total BDI-II Score From Baseline to Week 4
4 weeks
Study Arms (2)
Resveratrol Pill
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
- current depression.
You may not qualify if:
- serious or unstable disease;
- antidepressants intake.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Russian Academy of Medical Scienceslead
- Russian Science Foundationcollaborator
Study Sites (1)
Lyubomir I. Aftanas
Novosibirsk, 630117, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lyubomir Aftanas
- Organization
- Institute of Physiology and Basic Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Institute of Physiology and Basic Medicine, Principal Investigator
Study Record Dates
First Submitted
December 11, 2017
First Posted
December 27, 2017
Study Start
July 4, 2018
Primary Completion
August 27, 2019
Study Completion
September 18, 2019
Last Updated
December 8, 2020
Results First Posted
November 17, 2020
Record last verified: 2020-11