Phase 4
N=22
Efficacy of Resveratrol in Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03384329 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change in Total HDRS-17 Score From Baseline to Week 4 — -7.2; -9.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Resveratrol Pill (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Russian Academy of Medical Sciences
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total HDRS-17 Score From Baseline to Week 4 |
-7.2; -9.9 | — |
| PRIMARY Change in SIRT1 Activity From Baseline to Week 4 |
-0.59; -0.02 | — |
| SECONDARY Change in Total BDI-II Score From Baseline to Week 4 |
-9.3; -9.7 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03384329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.