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Efficacy of Resveratrol in Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Resveratrol Pill
Placebos
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lyubomir I. Aftanas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol Pill

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Total HDRS-17 Score From Baseline to Week 4
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Change in SIRT1 Activity From Baseline to Week 4
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2017
Last Updated
November 17, 2020
Sponsor
Russian Academy of Medical Sciences
Collaborators
Russian Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03384329
Brief Title
Efficacy of Resveratrol in Depression
Official Title
Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
September 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences
Collaborators
Russian Science Foundation

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol Pill
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Resveratrol Pill
Intervention Description
Resveratrol 500 mg
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo Pills
Primary Outcome Measure Information:
Title
Change in Total HDRS-17 Score From Baseline to Week 4
Description
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Time Frame
4 weeks
Title
Change in SIRT1 Activity From Baseline to Week 4
Description
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Total BDI-II Score From Baseline to Week 4
Description
Beck Depression Inventory 21 items, total score range 0-63 (63 - worse)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lyubomir I. Aftanas
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation

12. IPD Sharing Statement

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Efficacy of Resveratrol in Depression

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