Efficacy of Resveratrol in Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384329
• Other study ID #: RESV-depression
• Status: Completed
• Phase: Phase 4
• Start date: July 4, 2018
• Est. completion date: September 18, 2019

Study information

• Verified date: November 2020
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 18, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Resveratrol Pill
Resveratrol 500 mg
• Placebos
Placebo Pills

Locations

Country	Name	City	State
Russian Federation	Lyubomir I. Aftanas	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences	Russian Science Foundation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in SIRT1 Activity From Baseline to Week 4	SIRT1 is enzyme sirtuin-1 which activity is measured in the blood	4 weeks
Secondary	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