Trial Outcomes & Findings for Efficacy of Resveratrol in Depression (NCT NCT03384329)
NCT ID: NCT03384329
Last Updated: 2020-12-08
Results Overview
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-12-08
Participant Flow
Eight enrolled patients dropped out during the 5-day run-in inpatient-study period
Participant milestones
| Measure |
Resveratrol Pill
Resveratrol Pill: Resveratrol 500 mg
|
Placebo
Placebos: Placebo Pills
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Resveratrol Pill
n=11 Participants
Resveratrol Pill: Resveratrol 500 mg
|
Placebo
n=11 Participants
Placebos: Placebo Pills
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.8 • n=11 Participants
|
38.1 years
STANDARD_DEVIATION 10.8 • n=11 Participants
|
37.4 years
STANDARD_DEVIATION 9.7 • n=22 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
12 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
10 Participants
n=22 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
22 participants
n=22 Participants
|
|
Body mass index
|
24.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=11 Participants
|
22.4 kg/m^2
STANDARD_DEVIATION 3.7 • n=11 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 4.0 • n=22 Participants
|
|
Major depressive disorder (MDD) type
recurrent
|
1 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
7 Participants
n=22 Participants
|
|
Major depressive disorder (MDD) type
single
|
4 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
6 Participants
n=22 Participants
|
|
Major depressive disorder (MDD) type
persistent
|
6 Participants
n=11 Participants
|
3 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
|
Winter season
|
8 participants
n=11 Participants
|
9 participants
n=11 Participants
|
17 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 4 weeksHamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Outcome measures
| Measure |
Resveratrol Pill
n=11 Participants
Resveratrol Pill: Resveratrol 500 mg
|
Placebo
n=11 Participants
Placebos: Placebo Pills
|
|---|---|---|
|
Change in Total HDRS-17 Score From Baseline to Week 4
|
-7.2 score on a scale
Standard Deviation 5.3
|
-9.9 score on a scale
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: 4 weeksSIRT1 is enzyme sirtuin-1 which activity is measured in the blood
Outcome measures
| Measure |
Resveratrol Pill
n=11 Participants
Resveratrol Pill: Resveratrol 500 mg
|
Placebo
n=11 Participants
Placebos: Placebo Pills
|
|---|---|---|
|
Change in SIRT1 Activity From Baseline to Week 4
|
-0.59 units
Standard Deviation 1.14
|
-0.02 units
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: 4 weeksBeck Depression Inventory 21 items, total score range 0-63 (63 - worse)
Outcome measures
| Measure |
Resveratrol Pill
n=11 Participants
Resveratrol Pill: Resveratrol 500 mg
|
Placebo
n=11 Participants
Placebos: Placebo Pills
|
|---|---|---|
|
Change in Total BDI-II Score From Baseline to Week 4
|
-9.3 score on a scale
Standard Deviation 11.5
|
-9.7 score on a scale
Standard Deviation 10.5
|
Adverse Events
Resveratrol Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lyubomir Aftanas
Institute of Physiology and Basic Medicine
Phone: +7-913-912-2228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place