Trial Outcomes & Findings for Topiramate and Prolonged Exposure (NCT NCT03176953)
NCT ID: NCT03176953
Last Updated: 2023-11-18
Results Overview
PTSD symptom diagnostic interview CAPS-5 score range = 0 - 80 Higher scores = more severe PTSD symptoms
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Change from baseline to 16 weeks
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Prolonged Exposure + Topiramate
psychotherapy plus active medication
topiramate: active medication
prolonged exposure: psychotherapy
|
Prolonged Exposure + Placebo
psychotherapy plus placebo medication
prolonged exposure: psychotherapy
placebo: non-active medication
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topiramate and Prolonged Exposure
Baseline characteristics by cohort
| Measure |
Prolonged Exposure + Topiramate
n=50 Participants
psychotherapy plus active medication
topiramate: active medication
prolonged exposure: psychotherapy
|
Prolonged Exposure + Placebo
n=50 Participants
psychotherapy plus placebo medication
prolonged exposure: psychotherapy
placebo: non-active medication
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.86 years
STANDARD_DEVIATION 12.39 • n=5 Participants
|
44.67 years
STANDARD_DEVIATION 12.90 • n=7 Participants
|
45.27 years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
|
Sex/Gender, Customized
sex · male
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex/Gender, Customized
sex · female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Education
GED/High School Diploma
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Some college
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Education
College degree
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Education
Missing
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: All randomized participants
PTSD symptom diagnostic interview CAPS-5 score range = 0 - 80 Higher scores = more severe PTSD symptoms
Outcome measures
| Measure |
Prolonged Exposure + Topiramate
n=50 Participants
psychotherapy plus active medication
topiramate: active medication
prolonged exposure: psychotherapy
|
Prolonged Exposure + Placebo
n=50 Participants
psychotherapy plus placebo medication
prolonged exposure: psychotherapy
placebo: non-active medication
|
|---|---|---|
|
CAPS-5 Change
16-week CAPS
|
21.006 score on a scale
Standard Error 1.988
|
29.872 score on a scale
Standard Error 2.016
|
|
CAPS-5 Change
baseline CAPS
|
36.720 score on a scale
Standard Error 1.794
|
38.600 score on a scale
Standard Error 1.794
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weekssubstance use severity score range = 0 - 100% of heavy drinking days higher scores = greater percentage of total days that included heavy drinking
Outcome measures
| Measure |
Prolonged Exposure + Topiramate
n=50 Participants
psychotherapy plus active medication
topiramate: active medication
prolonged exposure: psychotherapy
|
Prolonged Exposure + Placebo
n=50 Participants
psychotherapy plus placebo medication
prolonged exposure: psychotherapy
placebo: non-active medication
|
|---|---|---|
|
Timeline Followback Interview (TLFB)
Baseline
|
53.5 percentage of days
Standard Error 3.6
|
52.1 percentage of days
Standard Error 3.6
|
|
Timeline Followback Interview (TLFB)
16 week
|
10.8 percentage of days
Standard Error 4.1
|
16.2 percentage of days
Standard Error 4.2
|
Adverse Events
Prolonged Exposure + Topiramate
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Prolonged Exposure + Placebo
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prolonged Exposure + Topiramate
n=50 participants at risk
psychotherapy plus active medication
topiramate: active medication
prolonged exposure: psychotherapy
|
Prolonged Exposure + Placebo
n=50 participants at risk
psychotherapy plus placebo medication
prolonged exposure: psychotherapy
placebo: non-active medication
|
|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
4.0%
2/50 • Number of events 2 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
0.00%
0/50 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
|
Social circumstances
arrest
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
|
General disorders
severe headache
|
0.00%
0/50 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
Other adverse events
| Measure |
Prolonged Exposure + Topiramate
n=50 participants at risk
psychotherapy plus active medication
topiramate: active medication
prolonged exposure: psychotherapy
|
Prolonged Exposure + Placebo
n=50 participants at risk
psychotherapy plus placebo medication
prolonged exposure: psychotherapy
placebo: non-active medication
|
|---|---|---|
|
Endocrine disorders
acidosis
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
0.00%
0/50 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
|
Skin and subcutaneous tissue disorders
skin rash
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
0.00%
0/50 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
|
Skin and subcutaneous tissue disorders
physical injury due to fighting or non-suicidal self-harm
|
4.0%
2/50 • Number of events 2 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
|
Social circumstances
incarceration due to parole violation
|
0.00%
0/50 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
2.0%
1/50 • Number of events 1 • Duration of study participation - 10 months
Definitions did not differ. Systematic assessment by clinicians during treatment phase and assessors during follow-up phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place