Trial Outcomes & Findings for Depression, Obesity and Inflammatory Markers (NCT NCT02765100)
NCT ID: NCT02765100
Last Updated: 2020-07-01
Results Overview
Scale ranges from 0-52. Greater change means greater improvement of depression from baseline to week 8.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline; week 8
Results posted on
2020-07-01
Participant Flow
Participant milestones
| Measure |
Low CRP
patients with a baseline C-ReactiveProtein value =/\< 3 treated with minocycline 200 mg/d
|
High CRP
patients with a baseline C-ReactiveProtein value \>3 treated with minocycline 200 mg/d
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Low CRP
patients with a baseline C-ReactiveProtein value =/\< 3 treated with minocycline 200 mg/d
|
High CRP
patients with a baseline C-ReactiveProtein value \>3 treated with minocycline 200 mg/d
|
|---|---|---|
|
Overall Study
subject found ineligible after baseline
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low CRP
n=9 Participants
CRP =/\< 3
|
High CRP
n=12 Participants
CRP \> 3
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 7.5 • n=9 Participants
|
44.5 years
STANDARD_DEVIATION 14.0 • n=12 Participants
|
48.3 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
9 Participants
n=12 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
3 Participants
n=12 Participants
|
10 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=9 Participants
|
11 participants
n=12 Participants
|
19 participants
n=21 Participants
|
|
Region of Enrollment
Qatar
|
1 participants
n=9 Participants
|
1 participants
n=12 Participants
|
2 participants
n=21 Participants
|
|
Hamilton Depression Scale (HAMD)
|
24.8 units on a scale
STANDARD_DEVIATION 6.5 • n=9 Participants
|
23.0 units on a scale
STANDARD_DEVIATION 4.1 • n=12 Participants
|
23.8 units on a scale
STANDARD_DEVIATION 5.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; week 8Population: Three participants not analyzed due to withdrawal from study
Scale ranges from 0-52. Greater change means greater improvement of depression from baseline to week 8.
Outcome measures
| Measure |
Low CRP
n=8 Participants
patients with baseline CRP =/\< 3
|
High CRP
n=10 Participants
patients with baseline CRP \> 3
|
|---|---|---|
|
Change in Depression as Measured by the Hamilton Depression Scale Collected at Baseline and Week 8
|
-12.2 units on a scale
Standard Deviation 3.4
|
-12.0 units on a scale
Standard Deviation 3.1
|
Adverse Events
Low CRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High CRP
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place