Trial Outcomes & Findings for Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans (NCT NCT03340350)
NCT ID: NCT03340350
Last Updated: 2020-07-09
Results Overview
PTSD symptom severity was assessed using total scores on the Past Month version of the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5). Total scores on the CAPS-5 range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
COMPLETED
PHASE4
10 participants
Baseline and Week 12
2020-07-09
Participant Flow
Participant milestones
| Measure |
Minocycline
Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans
Baseline characteristics by cohort
| Measure |
Minocycline
n=10 Participants
Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12PTSD symptom severity was assessed using total scores on the Past Month version of the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5). Total scores on the CAPS-5 range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
PTSD Symptom Severity
Baseline
|
31.5 score on a scale
Standard Deviation 7.23
|
|
PTSD Symptom Severity
Week 12
|
23 score on a scale
Standard Deviation 7.62
|
PRIMARY outcome
Timeframe: Screening and Week 12Measure of inflammation
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Change in C-reactive Protein (CRP) Level
Screening
|
1.25 mg/dL
Standard Deviation 0.35
|
|
Change in C-reactive Protein (CRP) Level
Week 12
|
0.90 mg/dL
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Screening and Week 12Measure of inflammation
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Change in Interleukin 6 (IL-6) Level
Week 12
|
1.64 pg/mL
Standard Deviation 0.67
|
|
Change in Interleukin 6 (IL-6) Level
Screening
|
1.27 pg/mL
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: Screening and Week 12Measure of inflammation
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Change in Tumor Necrosis Factor Alpha (TNF-α) Level
Screening
|
1.14 pg/mL
Standard Deviation 0.31
|
|
Change in Tumor Necrosis Factor Alpha (TNF-α) Level
Week 12
|
1.13 pg/mL
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Screening and Week 12Depression symptom severity was assessed using total scores on the Beck Depression Inventory-II (BDI-II). Total scores on the BDI-II range from 0 to 63, with higher scores indicating greater severity of depression symptoms.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Depression Symptom Severity
Screening
|
24.5 score on a scale
Standard Deviation 12.71
|
|
Depression Symptom Severity
Week 12
|
20.75 score on a scale
Standard Deviation 5.19
|
SECONDARY outcome
Timeframe: Baseline and Week 12The Clinical Global Impressions Severity scale (CGI-S) was used to assess severity of illness. Scores on the CGI-S range from 0 to 7, with higher scores reflecting greater severity of illness.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Clinical Status (Severity)
Baseline
|
4.25 score on a scale
Standard Deviation 0.50
|
|
Clinical Status (Severity)
Week 12
|
4.00 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline and Week 12The Clinical Global Impressions Improvement scale (CGI-I) was used to assess global improvement in clinical status. Scores on the CGI-I range from 0 to 7, with lower scores reflecting greater improvement in clinical status.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Clinical Status (Improvement)
Baseline
|
4.00 score on a scale
Standard Deviation 0.00
|
|
Clinical Status (Improvement)
Week 12
|
3.25 score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline and Week 12The Trail Making Test (TMT) is a scale used to measure a type of executive functioning (i.e., higher-order cognitive function) called set shifting. The TMT is scored as time (in seconds) to complete Parts A and B of this task. A difference score was calculated (time to complete Part B minus time to complete Part A) to subtract the motor component of this task and provide a better estimate of executive functioning. Lower difference scores on the TMT indicate better set shifting.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Executive Functioning (Set Shifting)
Week 12
|
23.00 seconds
Standard Deviation 1.92
|
|
Executive Functioning (Set Shifting)
Baseline
|
43.75 seconds
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: Baseline and Week 12The Controlled Oral Word Association (COWA) is a scale used to measure a type of executive functioning (i.e., higher-order cognitive function) called verbal fluency. The COWA is scored as the total number of valid words produced in one minute for each of three letters, with 1 point scored for each valid word (score range: 0-no upper limit). Higher scores on the COWA indicate greater verbal fluency.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Executive Functioning (Verbal Fluency)
Baseline
|
31.00 number of words
Standard Deviation 4.00
|
|
Executive Functioning (Verbal Fluency)
Week 12
|
32.25 number of words
Standard Deviation 6.65
|
Adverse Events
Minocycline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minocycline
n=10 participants at risk
Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12
Minocycline: Minocycline capsule
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash/hives
|
20.0%
2/10 • 12 weeks
|
|
General disorders
Hospitalization
|
10.0%
1/10 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
10.0%
1/10 • 12 weeks
|
Additional Information
Sriram Ramaswamy, MD
VA Nebraska-Western Iowa Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place