Trial Outcomes & Findings for Open Treatment of Minocycline in Geriatric Depression (NCT NCT01659320)
NCT ID: NCT01659320
Last Updated: 2017-05-12
Results Overview
A published and widely-used scale for rating depression, the Montgomery Asberg Depression Rating Scale total scores range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-05-12
Participant Flow
Participant milestones
| Measure |
Minocycline
Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Minocycline
Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
We enrolled 16 subjects but 1 subject withdrew consent before any clinical baseline data could be collected.
Baseline characteristics by cohort
| Measure |
Minocycline
n=16 Participants
Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=16 Participants
|
|
Age, Continuous
|
72.13 years
STANDARD_DEVIATION 10.22 • n=16 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
24.67 units on a scale
STANDARD_DEVIATION 4.56 • n=15 Participants • We enrolled 16 subjects but 1 subject withdrew consent before any clinical baseline data could be collected.
|
|
Mini Mental State Examination (MMSE)
|
28.13 units on a scale
STANDARD_DEVIATION 1.72 • n=15 Participants • We enrolled 16 subjects but 1 subject withdrew consent before any clinical baseline data could be collected.
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Among 13 subjects who completed the study.
A published and widely-used scale for rating depression, the Montgomery Asberg Depression Rating Scale total scores range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Outcome measures
| Measure |
Minocycline
n=13 Participants
Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks
|
|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
16.62 units on a scale
Standard Deviation 7.19
|
Adverse Events
Minocycline
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minocycline
n=16 participants at risk
Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 2 • up to 8 weeks
|
|
Cardiac disorders
Ventricular arrhythmia
|
6.2%
1/16 • Number of events 1 • up to 8 weeks
|
Additional Information
Dr. George Alexopoulos, M.D.
Weill Cornell Medical College
Phone: 914-997-5767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place