Trial Outcomes & Findings for Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence (NCT NCT01847469)
NCT ID: NCT01847469
Last Updated: 2020-03-16
Results Overview
Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-03-16
Participant Flow
Participant milestones
| Measure |
Zonisamide
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
|
Overall Study
COMPLETED
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Zonisamide
n=18 Participants
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
n=6 Participants
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.28 years
STANDARD_DEVIATION 12.94 • n=99 Participants
|
47.83 years
STANDARD_DEVIATION 11.57 • n=107 Participants
|
45.17 years
STANDARD_DEVIATION 12.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
6 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The intention to treat population was used in the analysis.
Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.
Outcome measures
| Measure |
Zonisamide
n=18 Participants
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
n=6 Participants
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
|---|---|---|
|
Number of Drinking Days
Baseline
|
46.87 days
Standard Error 5.63
|
51.00 days
Standard Error 9.48
|
|
Number of Drinking Days
12 weeks
|
7.44 days
Standard Error 5.47
|
17.33 days
Standard Error 9.48
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The intention to treat population was used in the analysis.
Timeline Follow Back (TLFB) will be used to document the number of "heavy" drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women.
Outcome measures
| Measure |
Zonisamide
n=18 Participants
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
n=6 Participants
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
|---|---|---|
|
Number of Heavy Drinking Days
Baseline
|
43.94 days
Standard Error 5.37
|
31.50 days
Standard Error 9.05
|
|
Number of Heavy Drinking Days
12 weeks
|
5.50 days
Standard Error 5.22
|
4.16 days
Standard Error 9.05
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The intention to treat population was used in the analysis.
The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates "none". The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms.
Outcome measures
| Measure |
Zonisamide
n=18 Participants
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
n=6 Participants
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS) Total Score
Baseline
|
67.33 units on a scale
Standard Error 5.49
|
72.83 units on a scale
Standard Error 9.51
|
|
Clinician-Administered PTSD Scale (CAPS) Total Score
12 weeks
|
30.83 units on a scale
Standard Error 6.02
|
23.80 units on a scale
Standard Error 11.21
|
Adverse Events
Zonisamide
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zonisamide
n=18 participants at risk
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
n=6 participants at risk
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
General disorders
Fall
|
0.00%
0/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
Infections and infestations
Breast Swelling
|
5.6%
1/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
0.00%
0/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
Other adverse events
| Measure |
Zonisamide
n=18 participants at risk
Participants in this arm will receive zonisamide for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
|
Placebo
n=6 participants at risk
Participants in this arm will receive placebo medication for 12 weeks.
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Placebo
|
|---|---|---|
|
General disorders
Difficulty Sleeping
|
33.3%
6/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
33.3%
2/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
Psychiatric disorders
Depressed Mood
|
33.3%
6/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
General disorders
Fatigue
|
16.7%
3/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
General disorders
Drowsiness
|
16.7%
3/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
Psychiatric disorders
Decreased Libido
|
16.7%
3/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
33.3%
2/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
Psychiatric disorders
Irritability
|
16.7%
3/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
|
Nervous system disorders
Memory Impairment
|
16.7%
3/18 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
16.7%
1/6 • 12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
|
Additional Information
Dr. Ismene Petrakis
Yale University School of Medicine, VA Connecticut Healthcare System
Phone: (203) 932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place