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OpenTrials
Completed

NCT Number: NCT03384329

Efficacy of Resveratrol in Depression

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lyubomir I. Aftanas

Novosibirsk, 630117, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol Pill

Drug

Resveratrol 500 mg

Placebos

Drug

Placebo Pills

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Russian Academy of Medical Sciences

Other

Collaborators

  • Russian Science Foundation

Registry information

Official study title

Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2017
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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