Trial Outcomes & Findings for Minocycline and Aspirin in the Treatment of Bipolar Depression (NCT NCT01429272)
NCT ID: NCT01429272
Last Updated: 2018-01-11
Results Overview
Response to treatment defined as a \>50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
Six weeks
Results posted on
2018-01-11
Participant Flow
Participant milestones
| Measure |
Placebo & Placebo
Placebo for minocycline \& placebo for aspirin
placebo: placebo for minocycline and/or aspirin
|
Minocycline & Aspirin
Minocycline 100mg PO BID for 6 weeks \& Aspirin 81 mg PO BID for 6 weeks
Minocycline: 100 mg po bid for 6 weeks
Aspirin: 81 mg po bid for 6 weeks
|
Placebo + Minocycline
placebo aspirin + active minocycline
|
Placebo + Aspirin
placebo minocycline + active aspirin
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
19
|
19
|
|
Overall Study
COMPLETED
|
24
|
22
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline and Aspirin in the Treatment of Bipolar Depression
Baseline characteristics by cohort
| Measure |
Placebo & Placebo
n=30 Participants
Placebo for minocycline \& placebo for aspirin
placebo: placebo for minocycline and/or aspirin
|
Minocycline & Aspirin
n=31 Participants
Minocycline 100mg PO BID for 6 weeks \& Aspirin 81 mg PO BID for 6 weeks
Minocycline: 100 mg po bid for 6 weeks
Aspirin: 81 mg po bid for 6 weeks
|
Placebo + Minocycline
n=19 Participants
placebo aspirin + active minocycline
|
Placebo + Aspirin
n=19 Participants
placebo minocycline + active aspirin
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
40.8 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
40.8 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
44.8 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
40.6 Years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
41.5 Years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Montgomery-Asberg Depression Rating Score
|
29.2 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
28.0 units on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants
|
27.2 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
25.9 units on a scale
STANDARD_DEVIATION 6.5 • n=4 Participants
|
27.8 units on a scale
STANDARD_DEVIATION 5.9 • n=21 Participants
|
|
Measure of Inflammation using the C-Reactive Protein (CRP) measurement
|
4.4 mg/L
STANDARD_DEVIATION 5.3 • n=5 Participants
|
8.2 mg/L
STANDARD_DEVIATION 12.9 • n=7 Participants
|
4.3 mg/L
STANDARD_DEVIATION 5.5 • n=5 Participants
|
4.5 mg/L
STANDARD_DEVIATION 4.9 • n=4 Participants
|
5.6 mg/L
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Interleukin 6 (IL-6)
|
0.9 pg/ML
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.0 pg/ML
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.9 pg/ML
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.1 pg/ML
STANDARD_DEVIATION 0.7 • n=4 Participants
|
1.0 pg/ML
STANDARD_DEVIATION 0.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: Six weeksPopulation: Note numbers do not match the participants flow because participants who did not return for at least one post treatment visit could not be included in the analysis.
Response to treatment defined as a \>50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.
Outcome measures
| Measure |
Placebo & Placebo
n=28 Participants
Placebo for minocycline \& placebo for aspirin
placebo: placebo for minocycline and/or aspirin
|
Minocycline & Aspirin
n=30 Participants
Minocycline 100mg PO BID for 6 weeks \& Aspirin 81 mg PO BID for 6 weeks
Minocycline: 100 mg po bid for 6 weeks
Aspirin: 81 mg po bid for 6 weeks
|
Placebo + Minocycline
n=18 Participants
placebo aspirin + active minocycline
|
Placebo + Aspirin
n=19 Participants
placebo minocycline + active aspirin
|
|---|---|---|---|---|
|
Treatment Response
|
21 Percentage of Participants
|
44 Percentage of Participants
|
25 Percentage of Participants
|
50 Percentage of Participants
|
SECONDARY outcome
Timeframe: Six weeksPopulation: Note numbers do not match the participants flow because participants who did not return for at least one post treatment visit could not be included in the analysis.
Remission defined as a score of \<11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.
Outcome measures
| Measure |
Placebo & Placebo
n=28 Participants
Placebo for minocycline \& placebo for aspirin
placebo: placebo for minocycline and/or aspirin
|
Minocycline & Aspirin
n=30 Participants
Minocycline 100mg PO BID for 6 weeks \& Aspirin 81 mg PO BID for 6 weeks
Minocycline: 100 mg po bid for 6 weeks
Aspirin: 81 mg po bid for 6 weeks
|
Placebo + Minocycline
n=18 Participants
placebo aspirin + active minocycline
|
Placebo + Aspirin
n=19 Participants
placebo minocycline + active aspirin
|
|---|---|---|---|---|
|
Remission Rate
|
14 percentage of participants
|
26 percentage of participants
|
6 percentage of participants
|
28 percentage of participants
|
Adverse Events
Placebo & Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minocycline & Aspirin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + Minocycline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + Aspirin
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
Jonathan Savitz; Principal Investigator
Laureate Institute for Brain Research
Phone: 918 502 5104
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place