Trial Outcomes & Findings for A Placebo-Controlled Trial of D-Cycloserine and Exposure Therapy for Combat-PTSD (NCT NCT00371176)
NCT ID: NCT00371176
Last Updated: 2014-02-04
Results Overview
A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.
COMPLETED
NA
26 participants
Pre Intervention
2014-02-04
Participant Flow
The recruitment period was 2007 to 2011. Participants were recruited through VA clinician referrals and public advertising (e.g., flyers and radio ads).
Participant milestones
| Measure |
D-Cycloserine Plus Exposure
Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a 50 mg DCS pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
|
Placebo Plus Exposure
Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a placebo pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
Completed Treatment
|
10
|
9
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Placebo-Controlled Trial of D-Cycloserine and Exposure Therapy for Combat-PTSD
Baseline characteristics by cohort
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32.77 years
STANDARD_DEVIATION 9.85 • n=99 Participants
|
31.62 years
STANDARD_DEVIATION 9.10 • n=107 Participants
|
32.19 years
STANDARD_DEVIATION 9.31 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre InterventionA 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Clinician Administered PTSD Scale-IV
|
69.85 units on a scale
Standard Deviation 23.24
|
73.38 units on a scale
Standard Deviation 16.35
|
PRIMARY outcome
Timeframe: Post InterventionA 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Clinician Administered PTSD Scale-IV
|
72.33 units on a scale
Standard Deviation 28.68
|
53.73 units on a scale
Standard Deviation 26.22
|
PRIMARY outcome
Timeframe: 3 month follow-upA 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=9 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=11 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Clinician Administered PTSD Scale-IV
|
62.57 units on a scale
Standard Deviation 32.17
|
58.20 units on a scale
Standard Deviation 26.17
|
PRIMARY outcome
Timeframe: 6 month follow-upA 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=9 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=11 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Clinician Administered PTSD Scale-IV
|
62.20 units on a scale
Standard Deviation 32.17
|
55.50 units on a scale
Standard Deviation 27.02
|
SECONDARY outcome
Timeframe: Pre InterventionA 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
PTSD Checklist
|
37.85 units on a scale
Standard Deviation 8.76
|
39.00 units on a scale
Standard Deviation 8.77
|
SECONDARY outcome
Timeframe: Post interventionA 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
PTSD Checklist
|
34.11 units on a scale
Standard Deviation 21.09
|
24.18 units on a scale
Standard Deviation 14.95
|
SECONDARY outcome
Timeframe: 3 month follow-upA 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=9 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=11 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
PTSD Checklist
|
33.29 units on a scale
Standard Deviation 14.68
|
26.91 units on a scale
Standard Deviation 16.40
|
SECONDARY outcome
Timeframe: 6 month follow-upA 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=9 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=11 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
PTSD Checklist
|
29.20 units on a scale
Standard Deviation 13.16
|
27.25 units on a scale
Standard Deviation 15.83
|
SECONDARY outcome
Timeframe: Pre interventionA 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Beck Depression Inventory
|
24.85 units on a scale
Standard Deviation 15.31
|
21.48 units on a scale
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Post interventionA 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=13 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Beck Depression Inventory
|
28.56 units on a scale
Standard Deviation 16.25
|
14.18 units on a scale
Standard Deviation 10.81
|
SECONDARY outcome
Timeframe: 3 month follow-upA 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=9 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=11 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Beck Depression Inventory
|
24.57 units on a scale
Standard Deviation 14.43
|
13.90 units on a scale
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: 6 month follow-upA 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.
Outcome measures
| Measure |
D-Cycloserine Plus Exposure
n=9 Participants
Brief imaginal exposure therapy plus DCS pill
|
Placebo Plus Exposure
n=11 Participants
Brief imaginal exposure therapy plus Placebo pill
|
|---|---|---|
|
Beck Depression Inventory
|
22.25 units on a scale
Standard Deviation 17.73
|
15.38 units on a scale
Standard Deviation 11.43
|
Adverse Events
D-Cycloserine Plus Exposure
Placebo Plus Exposure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place