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Efficacy of Resveratrol in Depression

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ClinicalTrials.gov Identifier: NCT03384329
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
Russian Science Foundation
Information provided by (Responsible Party):
Lyubomir I. Aftanas, Russian Academy of Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Depression Drug: Resveratrol Pill Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
Actual Study Start Date : July 4, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Resveratrol Pill Drug: Resveratrol Pill
Resveratrol 500 mg

Placebo Comparator: Placebo Drug: Placebos
Placebo Pills




Primary Outcome Measures :
  1. Change from baseline total score of HDRS-17 [ Time Frame: at 1 month ]
    Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)

  2. Change from baseline SIRT1 enzymatic activity in the blood [ Time Frame: at 1 month ]
    (enzyme sirtuin-1 activity)


Secondary Outcome Measures :
  1. Change from baseline total score of BDI-II [ Time Frame: at 1 month ]
    Beck Depression Inventory 21 items, total score range 0-63 (63 - worse)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384329


Locations
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Russian Federation
Lyubomir I. Aftanas Recruiting
Novosibirsk, Russian Federation, 630117
Contact: Lyubomir I. Aftanas, MD    3359855 ext (007)383    liaftanas@gmail.com   
Sponsors and Collaborators
Russian Academy of Medical Sciences
Russian Science Foundation

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Responsible Party: Lyubomir I. Aftanas, Director of the Institute of Physiology and Basic Medicine, Principal Investigator, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03384329     History of Changes
Other Study ID Numbers: RESV-depression
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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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
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents