Trial Outcomes & Findings for Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD) (NCT NCT01517711)
NCT ID: NCT01517711
Last Updated: 2022-08-31
Results Overview
The Clinician-Administered PTSD Scale (CAPS) is an interview-based measure of severity of PTSD symptoms. A total score is calculated with a range of 0-136, with higher numbers indicating more severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Weeks 0 (baseline),1, 2, 4, 6
Results posted on
2022-08-31
Participant Flow
41 subjects were consented to achieve sample of 40; one never returned for evaluation.
40 evaluable subjects
Participant milestones
| Measure |
Tramadol ER
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
20
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Tramadol ER
n=22 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo
n=18 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Total
n=40 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
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
32.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0 (baseline),1, 2, 4, 6Population: 33 men and 7 women with PTSD
The Clinician-Administered PTSD Scale (CAPS) is an interview-based measure of severity of PTSD symptoms. A total score is calculated with a range of 0-136, with higher numbers indicating more severe symptoms.
Outcome measures
| Measure |
Tramadol ER Men
n=20 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Men
n=13 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Tramadol ER Women
n=2 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Women
n=5 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
|---|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
Week 0
|
79.1 units on a scale
Standard Deviation 17.8
|
81.9 units on a scale
Standard Deviation 24.8
|
90.0 units on a scale
Standard Deviation 5.7
|
91.0 units on a scale
Standard Deviation 19.0
|
|
Clinician-Administered PTSD Scale (CAPS)
Week 1
|
62.5 units on a scale
Standard Deviation 24.7
|
69.8 units on a scale
Standard Deviation 25.0
|
68.5 units on a scale
Standard Deviation 10.6
|
71.0 units on a scale
Standard Deviation 24.3
|
|
Clinician-Administered PTSD Scale (CAPS)
Week 2
|
54.4 units on a scale
Standard Deviation 25.7
|
68.5 units on a scale
Standard Deviation 26.2
|
67.0 units on a scale
Standard Deviation 31.1
|
62.2 units on a scale
Standard Deviation 15.4
|
|
Clinician-Administered PTSD Scale (CAPS)
Week 4
|
46.4 units on a scale
Standard Deviation 30.2
|
61.0 units on a scale
Standard Deviation 28.4
|
39.5 units on a scale
Standard Deviation 55.9
|
47.0 units on a scale
Standard Deviation 14.3
|
|
Clinician-Administered PTSD Scale (CAPS)
Week 6
|
46.5 units on a scale
Standard Deviation 32.2
|
51.0 units on a scale
Standard Deviation 28.6
|
36.0 units on a scale
Standard Deviation 50.9
|
41.0 units on a scale
Standard Deviation 14.4
|
PRIMARY outcome
Timeframe: Week 6, assessing clinician's judgment of change from week 0 to week 6Population: 33 men and 7 women with PTSD
The Clinicial Global Impression - Improvement (CGI-I) is a single item rated by a clinician. The range is 1 (very much improved)) to 7 (very much worse).
Outcome measures
| Measure |
Tramadol ER Men
n=20 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Men
n=13 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Tramadol ER Women
n=2 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Women
n=5 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
|---|---|---|---|---|
|
Clinical Global Impression -- Improvement (CGI-I) -- Subject
|
2.3 units on a scale
Standard Deviation 1.1
|
2.6 units on a scale
Standard Deviation 1.1
|
2.0 units on a scale
Standard Deviation 1.4
|
1.6 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Change from week 0 to 6Population: 33 men and 7 women with PTSD
Self-rated 100-mm visual analog scales \[0 to 100 scale; higher score indicates more of the rated state\] to rate poor sleep, happiness, irritability, nervousness and pain. Change is calculated by subtracting week 6 from week 0.
Outcome measures
| Measure |
Tramadol ER Men
n=20 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Men
n=13 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Tramadol ER Women
n=2 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Women
n=5 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
|---|---|---|---|---|
|
Visual Analog Scales (VAS)
Poor sleep
|
26.8 change in mm
Standard Deviation 38.5
|
6.7 change in mm
Standard Deviation 31.5
|
51.0 change in mm
Standard Deviation 31.1
|
32.8 change in mm
Standard Deviation 14.1
|
|
Visual Analog Scales (VAS)
Happiness
|
-18.5 change in mm
Standard Deviation 33.4
|
-11.0 change in mm
Standard Deviation 27.3
|
-40.3 change in mm
Standard Deviation 2.5
|
-29.6 change in mm
Standard Deviation 42.2
|
|
Visual Analog Scales (VAS)
Irritability
|
18.0 change in mm
Standard Deviation 30.5
|
14.2 change in mm
Standard Deviation 39.4
|
52.5 change in mm
Standard Deviation 16.3
|
39.0 change in mm
Standard Deviation 22.4
|
|
Visual Analog Scales (VAS)
Nervousness
|
15.0 change in mm
Standard Deviation 31.9
|
9.5 change in mm
Standard Deviation 24.3
|
34.0 change in mm
Standard Deviation 5.7
|
36.4 change in mm
Standard Deviation 26.9
|
|
Visual Analog Scales (VAS)
Pain
|
7.5 change in mm
Standard Deviation 22.8
|
10.4 change in mm
Standard Deviation 21.3
|
41.0 change in mm
Standard Deviation 1.4
|
5.6 change in mm
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: Weeks 0, 1, 2, 4 and 6Population: 33 men and 7 women with PTSD
Quick Inventory of Depressive Symptoms - Self Report (QIDS) is a self-report scale of severity of depression. A total score is calculated with a range of 0 to 27, with higher numbers indicating greater severity.
Outcome measures
| Measure |
Tramadol ER Men
n=20 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Men
n=13 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Tramadol ER Women
n=2 Participants
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo Women
n=5 Participants
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
|---|---|---|---|---|
|
Quick Inventory of Depressive Symptoms (QIDS)
QIDS week 0
|
11.2 units on a scale
Standard Deviation 4.2
|
13.7 units on a scale
Standard Deviation 4.4
|
15.5 units on a scale
Standard Deviation 2.1
|
12.6 units on a scale
Standard Deviation 4.8
|
|
Quick Inventory of Depressive Symptoms (QIDS)
QIDS week 1
|
8.7 units on a scale
Standard Deviation 4.8
|
11.8 units on a scale
Standard Deviation 4.2
|
11.0 units on a scale
Standard Deviation 5.7
|
8.4 units on a scale
Standard Deviation 4.2
|
|
Quick Inventory of Depressive Symptoms (QIDS)
QIDS week 2
|
7.7 units on a scale
Standard Deviation 4.7
|
11.6 units on a scale
Standard Deviation 5.6
|
12.0 units on a scale
Standard Deviation 9.9
|
7.0 units on a scale
Standard Deviation 2.2
|
|
Quick Inventory of Depressive Symptoms (QIDS)
QIDS week 4
|
7.7 units on a scale
Standard Deviation 5.6
|
10.0 units on a scale
Standard Deviation 5.2
|
9.0 units on a scale
Standard Deviation 8.5
|
7.1 units on a scale
Standard Deviation 4.6
|
|
Quick Inventory of Depressive Symptoms (QIDS)
QIDS week 6
|
6.7 units on a scale
Standard Deviation 4.8
|
7.1 units on a scale
Standard Deviation 4.1
|
6.5 units on a scale
Standard Deviation 4.9
|
4.5 units on a scale
Standard Deviation 1.7
|
Adverse Events
Tramadol ER
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tramadol ER
n=22 participants at risk
Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
Placebo
n=18 participants at risk
Placebo: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
|
|---|---|---|
|
Nervous system disorders
Headache
|
31.8%
7/22 • 7 weeks
Adverse events were assessed via study measures and clinician interview.
|
38.9%
7/18 • 7 weeks
Adverse events were assessed via study measures and clinician interview.
|
Additional Information
Dr. Thomas Geracioti, Principle Investigator
University of Cincinnati College of Medicine
Phone: 513-748-9825
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place