Depression
Conditions
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).
Interventions
DRUGResveratrol Pill
Resveratrol 500 mg
DRUGPlacebos
Placebo Pills
Sponsors
Russian Science Foundation
Russian Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total HDRS-17 Score From Baseline to Week 4 | 4 weeks | Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse) |
| Change in SIRT1 Activity From Baseline to Week 4 | 4 weeks | SIRT1 is enzyme sirtuin-1 which activity is measured in the blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total BDI-II Score From Baseline to Week 4 | 4 weeks | Beck Depression Inventory 21 items, total score range 0-63 (63 - worse) |
Countries
Russia
Participant flow
Pre-assignment details
Eight enrolled patients dropped out during the 5-day run-in inpatient-study period
Participants by arm
| Arm | Count |
|---|---|
| Resveratrol Pill Resveratrol Pill: Resveratrol 500 mg | 11 |
| Placebo Placebos: Placebo Pills | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Resveratrol Pill | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Continuous | 36.7 years STANDARD_DEVIATION 8.8 | 38.1 years STANDARD_DEVIATION 10.8 | 37.4 years STANDARD_DEVIATION 9.7 |
| Body mass index | 24.3 kg/m^2 STANDARD_DEVIATION 4.1 | 22.4 kg/m^2 STANDARD_DEVIATION 3.7 | 23.3 kg/m^2 STANDARD_DEVIATION 4 |
| Major depressive disorder (MDD) type persistent | 6 Participants | 3 Participants | 9 Participants |
| Major depressive disorder (MDD) type recurrent | 1 Participants | 6 Participants | 7 Participants |
| Major depressive disorder (MDD) type single | 4 Participants | 2 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Russia | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
| Winter season | 8 participants | 9 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in SIRT1 Activity From Baseline to Week 4
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resveratrol Pill | Change in SIRT1 Activity From Baseline to Week 4 | -0.59 units | Standard Deviation 1.14 |
| Placebo | Change in SIRT1 Activity From Baseline to Week 4 | -0.02 units | Standard Deviation 1.58 |
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)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resveratrol Pill | Change in Total HDRS-17 Score From Baseline to Week 4 | -7.2 score on a scale | Standard Deviation 5.3 |
| Placebo | Change in Total HDRS-17 Score From Baseline to Week 4 | -9.9 score on a scale | Standard Deviation 7 |
Secondary
Change in Total BDI-II Score From Baseline to Week 4
Beck Depression Inventory 21 items, total score range 0-63 (63 - worse)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resveratrol Pill | Change in Total BDI-II Score From Baseline to Week 4 | -9.3 score on a scale | Standard Deviation 11.5 |
| Placebo | Change in Total BDI-II Score From Baseline to Week 4 | -9.7 score on a scale | Standard Deviation 10.5 |