Trial Outcomes & Findings for Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth (NCT NCT01157416)
NCT ID: NCT01157416
Last Updated: 2017-04-21
Results Overview
The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
After 12 therapy sessions, up to 28 weeks.
Results posted on
2017-04-21
Participant Flow
Participant milestones
| Measure |
D-cycloserine Plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
Placebo Plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth
Baseline characteristics by cohort
| Measure |
D-cycloserine Plus CBT
n=17 Participants
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
Placebo Plus CBT
n=16 Participants
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
10.1 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 12 therapy sessions, up to 28 weeks.The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).
Outcome measures
| Measure |
D-cycloserine Plus CBT
n=15 Participants
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
Placebo Plus CBT
n=16 Participants
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
|---|---|---|
|
Child PTSD Symptom Scale (CPSS)
|
15.1 units on a scale
Standard Deviation 13.9
|
8.9 units on a scale
Standard Deviation 7.6
|
Adverse Events
D-cycloserine Plus CBT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Plus CBT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-cycloserine Plus CBT
n=17 participants at risk
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
Placebo Plus CBT
n=16 participants at risk
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
|
|---|---|---|
|
Nervous system disorders
drowsy
|
5.9%
1/17 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
headache
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
angry
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
dry mouth
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
aggressive
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/17
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
racing thoughts
|
0.00%
0/17
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
dizzy
|
5.9%
1/17 • Number of events 1
|
18.8%
3/16 • Number of events 3
|
Additional Information
Dr. Michael Scheeringa
Tulane University School of Medicine
Phone: 5046692322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place