Trial Outcomes & Findings for Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach (NCT NCT02553915)
NCT ID: NCT02553915
Last Updated: 2022-05-02
Results Overview
To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma interleukin-6 (IL-6) levels (pg/mL) or in mitogen-stimulated peripheral blood mononuclear cell (PBMC) Tumor Necrosis Factor-α (TNF-α) expression and secretion (pg/mL), when compared with placebo. Levels of inflammatory biomarkers were assessed at baseline (week 0) and at week 12 for comparison. Percent changes were calculated as relative to baseline values. Greater percent decrease indicates better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
61 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
Placebo
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
16
|
|
Overall Study
COMPLETED
|
11
|
14
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=15 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=15 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=16 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
56 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=39 Participants
|
42 years
STANDARD_DEVIATION 15 • n=41 Participants
|
44 years
STANDARD_DEVIATION 15 • n=35 Participants
|
46 years
STANDARD_DEVIATION 13 • n=31 Participants
|
46 years
STANDARD_DEVIATION 14 • n=146 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
46 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
21 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
34 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Unknown / Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
12 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
53 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=39 Participants
|
15 participants
n=41 Participants
|
15 participants
n=35 Participants
|
16 participants
n=31 Participants
|
61 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study completers with available biomarker data
To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma interleukin-6 (IL-6) levels (pg/mL) or in mitogen-stimulated peripheral blood mononuclear cell (PBMC) Tumor Necrosis Factor-α (TNF-α) expression and secretion (pg/mL), when compared with placebo. Levels of inflammatory biomarkers were assessed at baseline (week 0) and at week 12 for comparison. Percent changes were calculated as relative to baseline values. Greater percent decrease indicates better outcome.
Outcome measures
| Measure |
Placebo
n=10 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=11 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Percent Change in Plasma Concentration of Inflammatory Biomarkers IL-6 (pg/mL) and PBMC TNF-α (pg/mL)
% Change in Plasma IL-6 (pg/mL) at 12 weeks
|
1.92 percentage of change in plasma levels
Standard Deviation 30.24
|
-1.27 percentage of change in plasma levels
Standard Deviation 28.37
|
7.19 percentage of change in plasma levels
Standard Deviation 32.24
|
4.45 percentage of change in plasma levels
Standard Deviation 40.16
|
|
Percent Change in Plasma Concentration of Inflammatory Biomarkers IL-6 (pg/mL) and PBMC TNF-α (pg/mL)
% Change in PBMC TNF-alpha (pg/mL) at 12 weeks
|
8.59 percentage of change in plasma levels
Standard Deviation 45.82
|
-0.19 percentage of change in plasma levels
Standard Deviation 39.63
|
10.38 percentage of change in plasma levels
Standard Deviation 80.36
|
28.54 percentage of change in plasma levels
Standard Deviation 56.97
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study completers with available IDS-C30 data
To evaluate whether EPA treatment produces a decrease in ratings of depression severity after 12 weeks of treatment, when compared with placebo-treated subjects. Comparison is made between pre-treatment and post-12 weeks treatment. Inventory of Depressive Symptomatology-30 item-Clinician Rated (IDS-C30) is a depression severity scale, where lower scores indicate less depressive severity and higher scores indicate greater severity. Minimum score is 0 (zero) and maximum score is 84.
Outcome measures
| Measure |
Placebo
n=10 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=14 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=11 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Mean Change in Depression Severity Score (IDS-C30) After 12 Weeks of Treatment
Raw change at week 12
|
-17.6 score on a scale
Standard Deviation 7.82
|
-12.07 score on a scale
Standard Deviation 11.29
|
-12.73 score on a scale
Standard Deviation 17.32
|
-16.15 score on a scale
Standard Deviation 10.49
|
|
Mean Change in Depression Severity Score (IDS-C30) After 12 Weeks of Treatment
Baseline IDS-C30 Score
|
36.6 score on a scale
Standard Deviation 10.54
|
36.14 score on a scale
Standard Deviation 7.15
|
31.36 score on a scale
Standard Deviation 7.12
|
31.92 score on a scale
Standard Deviation 5.44
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study completers with available data
To evaluate whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression will mediate changes observed in ratings of depression. Inventory of Depressive Symptomatology-30 item-Clinician Rated (IDS-C30) is a depression severity scale, where lower scores indicate less depressive severity and higher scores indicate greater severity. Minimum score is 0 (zero) and maximum score is 84. Change in score over 12 weeks (from week 0 to week12) is calculated as a percent change from baseline. Greater percent change in the negative direction indicates better outcome.
Outcome measures
| Measure |
Placebo
n=10 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=14 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=11 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Percent Change in IDS-C Score After 12 Weeks of Treatment
|
-50.73 percentage change in score
Standard Deviation 25.24
|
-34.52 percentage change in score
Standard Deviation 31.51
|
-37.53 percentage change in score
Standard Deviation 50.92
|
-51.4 percentage change in score
Standard Deviation 30.23
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study completers with available biomarker data
To evaluate whether EPA treatment produces decreases in plasma levels of mitogen-stimulated PBMC IL-6 and TNF-α (both in in pg/mL). Percent change calculated by comparing week 12 to week 0 (baseline). Greater decrease (change in negative direction) indicates better outcome.
Outcome measures
| Measure |
Placebo
n=10 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=14 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=11 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Percent Change in Plasma Concentrations of Mitogen-stimulated PBMC IL-6 (pg/mL) and Plasma Tumor Necrosis Factor (TNF)-α (pg/mL)
% Change in Plasma PBMC IL-6 (pg/mL) at 12 weeks
|
41.6 percentage of change in plasma levels
Standard Deviation 78.1
|
-0.51 percentage of change in plasma levels
Standard Deviation 67.93
|
101.48 percentage of change in plasma levels
Standard Deviation 296.86
|
17.37 percentage of change in plasma levels
Standard Deviation 65.73
|
|
Percent Change in Plasma Concentrations of Mitogen-stimulated PBMC IL-6 (pg/mL) and Plasma Tumor Necrosis Factor (TNF)-α (pg/mL)
% Change in Plasma TNF-α (pg/mL) at 12 weeks
|
9.98 percentage of change in plasma levels
Standard Deviation 27.99
|
0.22 percentage of change in plasma levels
Standard Deviation 23.33
|
-1.95 percentage of change in plasma levels
Standard Deviation 18.63
|
-10.13 percentage of change in plasma levels
Standard Deviation 13.98
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Completers with available genetic marker data
To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes for IL-6 and TNF-α (in ΔΔCt units). Levels compared at week 0 (baseline) and at week 12 to obtain percent change from baseline. Greater decrease (change in negative direction) indicates better outcome.
Outcome measures
| Measure |
Placebo
n=9 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=12 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=11 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=10 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Percent Changes in Levels of Expression of Inflammation-related Genes for Interleukin (IL)-6 and Tumor Necrosis Factor (TNF)-α (in ΔΔCt Units)
% Change in IL-6 Gene expression (ΔΔCt) at 12 week
|
109.22 percentage of gene expression level
Standard Deviation 285.65
|
1426 percentage of gene expression level
Standard Deviation 4573
|
16.03 percentage of gene expression level
Standard Deviation 141.26
|
20.2 percentage of gene expression level
Standard Deviation 172.23
|
|
Percent Changes in Levels of Expression of Inflammation-related Genes for Interleukin (IL)-6 and Tumor Necrosis Factor (TNF)-α (in ΔΔCt Units)
% change in TNF-α Gene expression (ΔΔCt) at 12 wks
|
93.56 percentage of gene expression level
Standard Deviation 316.02
|
217.46 percentage of gene expression level
Standard Deviation 692.42
|
-36.09 percentage of gene expression level
Standard Deviation 37.32
|
-2.27 percentage of gene expression level
Standard Deviation 58.24
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study completers with available biomarker data
To evaluate whether EPA treatment produces decreases in plasma hs-CRP in mg/L. Levels compared at week o (baseline) and week 12 to obtain percent change. Greater percent decrease in the negative direction indicates better outcome.
Outcome measures
| Measure |
Placebo
n=10 Participants
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=11 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=13 Participants
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) in mg/L
|
7.22 percentage of change in plasma levels
Standard Deviation 54.27
|
-9.52 percentage of change in plasma levels
Standard Deviation 53.87
|
1.09 percentage of change in plasma levels
Standard Deviation 74.46
|
-17.96 percentage of change in plasma levels
Standard Deviation 35.08
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
EPA 1 g/Day
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
EPA 2 g/Day
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
EPA 4 g/Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo
|
EPA 1 g/Day
n=15 participants at risk
Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day
|
EPA 2 g/Day
n=15 participants at risk
Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day
|
EPA 4 g/Day
n=16 participants at risk
Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abnormal Propulsive movement of large bowel
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Acute vomiting
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Bloating
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Constipation alternating with diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Diarrhea/Loose stool
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Gastric reflux
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Increased frequency of bowel movements
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Renal and urinary disorders
Increased Urination
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Renal and urinary disorders
Acute Urinary Tract Infection
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
General disorders
Increased thirst
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Eye disorders
Acute conjunctivitis
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Immune system disorders
Allergy symptoms (environmental)
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Skin and subcutaneous tissue disorders
Burn injury (right thumb)
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Reproductive system and breast disorders
Ovarian cyst exacerbation
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Nervous system disorders
Dizziness of unknown cause
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Hematoma (toe)
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Gastrointestinal disorders
Increased appetite
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Ligament strain
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Lower limb numbness
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Infections and infestations
Shingles
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Musculoskeletal and connective tissue disorders
Hand laceration
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
General disorders
Tiredness
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Immune system disorders
Hives
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.2%
1/16 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Infections and infestations
Upper Respiratory Infection
|
13.3%
2/15 • Number of events 2 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
20.0%
3/15 • Number of events 3 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
25.0%
4/16 • Number of events 4 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
General disorders
Weight loss
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/15 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
6.7%
1/15 • Number of events 1 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
0.00%
0/16 • Adverse events were recorded only if they emerged or worsened during the course of the study. Each patient was treated in the double blind protocol for 12 weeks. During this time, adverse events were inquired about and recorded as endorsed by patients.
|
Additional Information
Dr David Mischoulon, Director, Depression Clinical and Research Program, MGH
Massachusetts General Hospital
Phone: 617-724-5198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place