Trial Outcomes & Findings for Minocycline for Bipolar Depression (NCT NCT01514422)
NCT ID: NCT01514422
Last Updated: 2017-01-30
Results Overview
Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
COMPLETED
PHASE4
20 participants
baseline and week 8
2017-01-30
Participant Flow
Study procedures were conducted between June 2011 and June 2013 at the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai.
Participant milestones
| Measure |
Minocycline
Minocycline 100 to 300mg per day for 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Minocycline
Minocycline 100 to 300mg per day for 8 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Minocycline for Bipolar Depression
Baseline characteristics by cohort
| Measure |
Minocycline
n=20 Participants
Minocycline 100 to 300mg per day for 8 weeks
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
|
Gender
Female
|
8 Participants
n=99 Participants
|
|
Gender
Male
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and week 8Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Outcome measures
| Measure |
Minocycline
n=19 Participants
Minocycline for 8 weeks
|
|---|---|
|
Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
|
-14.6 units on a scale
Interval -21.3 to -7.8
|
SECONDARY outcome
Timeframe: baseline and week 8Measured at baseline and week 8
Outcome measures
| Measure |
Minocycline
n=19 Participants
Minocycline for 8 weeks
|
|---|---|
|
Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan
|
0.001 mmol/L
Standard Deviation 0.0022
|
SECONDARY outcome
Timeframe: baseline and week 8Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).
Outcome measures
| Measure |
Minocycline
n=19 Participants
Minocycline for 8 weeks
|
|---|---|
|
Changes in Young Mania Rating Scale (YMRS)
baseline
|
1.8 units on a scale
Standard Deviation 2.3
|
|
Changes in Young Mania Rating Scale (YMRS)
week 8
|
1.1 units on a scale
Standard Deviation 0.9
|
Adverse Events
Minocycline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minocycline
n=20 participants at risk
Minocycline for 8 weeks
|
|---|---|
|
Renal and urinary disorders
Frequent need to urinate
|
25.0%
5/20
|
|
General disorders
Trouble sleeping
|
20.0%
4/20
|
|
General disorders
Fee!ing drowsy or sleepy
|
20.0%
4/20
|
|
Skin and subcutaneous tissue disorders
Dry mouth
|
20.0%
4/20
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps or stiffness
|
20.0%
4/20
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20
|
|
Gastrointestinal disorders
Appetite increased
|
20.0%
4/20
|
|
Nervous system disorders
Difficulties finding words
|
20.0%
4/20
|
|
Psychiatric disorders
Feeling nervous or hyper
|
15.0%
3/20
|
|
General disorders
Irritable
|
15.0%
3/20
|
|
Psychiatric disorders
Feeling strange or unreal
|
15.0%
3/20
|
|
Gastrointestinal disorders
Stomach or abdominal discomfort
|
15.0%
3/20
|
|
Renal and urinary disorders
Difficulty starting urination
|
15.0%
3/20
|
|
General disorders
Weight gain
|
15.0%
3/20
|
|
Psychiatric disorders
Nightmares or other disturbances
|
10.0%
2/20
|
|
Psychiatric disorders
Weakness or fatigue
|
10.0%
2/20
|
|
Nervous system disorders
Dizziness or faintness
|
10.0%
2/20
|
|
Nervous system disorders
Drooling or increase salivation
|
10.0%
2/20
|
|
Gastrointestinal disorders
Nausea or vomiting
|
10.0%
2/20
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20
|
|
Psychiatric disorders
Problems with sexual arousal
|
10.0%
2/20
|
|
Psychiatric disorders
Delayed or absent orgasm
|
10.0%
2/20
|
|
Gastrointestinal disorders
Appetite decreased
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
Skin rash or allergy
|
10.0%
2/20
|
|
Psychiatric disorders
Diminished mental acuity
|
10.0%
2/20
|
|
Psychiatric disorders
Apathy/emotional indifference
|
10.0%
2/20
|
|
Blood and lymphatic system disorders
Bruising
|
10.0%
2/20
|
|
Endocrine disorders
Hot flashes
|
10.0%
2/20
|
|
General disorders
Strange taste in mouth
|
10.0%
2/20
|
|
General disorders
Unable to sit still
|
10.0%
2/20
|
|
General disorders
Function impairment
|
10.0%
2/20
|
Additional Information
Dr. Dan V. Iosifescu
Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place