Efficacy of Resveratrol in Depression

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: Depression
• Intervention / Treatment: Drug: Resveratrol Pill; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630117
    • Lyubomir I. Aftanas

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebos; Placebo Pills
Experimental: Resveratrol Pill	Drug: 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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total BDI-II Score From Baseline to Week 4	Beck Depression Inventory 21 items, total score range 0-63 (63 - worse)	4 weeks

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences
• Collaborators: Russian Science Foundation

Study record dates

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: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• 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