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Efficacy of Resveratrol in Depression

NCT ID: NCT03384329

Last Updated: 2020-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2019-09-18

Brief Summary

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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).

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Resveratrol Pill

Group Type EXPERIMENTAL

Resveratrol Pill

Intervention Type DRUG

Resveratrol 500 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo Pills

Interventions

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Resveratrol Pill

Resveratrol 500 mg

Intervention Type DRUG

Placebos

Placebo Pills

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
* current depression.

Exclusion Criteria

* serious or unstable disease;
* antidepressants intake.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Russian Science Foundation

OTHER

Sponsor Role collaborator

Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Lyubomir I Aftanas, MD, PhD, DrSci., Prof.

Director of the Institute of Physiology and Basic Medicine, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lyubomir I. Aftanas

Novosibirsk, , Russia

Site Status

Countries

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Russia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RESV-depression

Identifier Type: -

Identifier Source: org_study_id