Trial Outcomes & Findings for D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents (NCT NCT01157429)

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

24 participants

Primary outcome timeframe

After 12 therapy sessions, up to 28 weeks.

Results posted on

2017-06-06

Participant Flow

A total of 63 youth were assessed. Only 47 meet all the inclusion and exclusion criteria and were offered treatment. Of those 47, only 24 were retained through session 5 of the treatment, which was the point of random allocation. Twenty-three subjects of the 47 subjects who were offered treatment dropped out prior to session 5.

Participant milestones

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 Pill 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	12	12
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-cycloserine Plus CBT n=12 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 Pill n=12 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=24 Participants Total of all reporting groups
Age, Continuous	15.7 years STANDARD_DEVIATION 1.6 • n=5 Participants	15.9 years STANDARD_DEVIATION 1.7 • n=7 Participants	15.8 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 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

Outcome measures
Measure	D-cycloserine Plus CBT n=8 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 Pill n=8 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 teh 12-session CBT protocol.
Child PTSD Symptom Scale (CPSS)	20.4 units on a scale Standard Deviation 9.7	11.0 units on a scale Standard Deviation 8.9

Adverse Events

D-cycloserine Plus CBT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Pill

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	D-cycloserine Plus CBT n=12 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 Pill n=12 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 teh 12-session CBT protocol.
Nervous system disorders drowsy	8.3% 1/12 • Number of events 2 • 2 months	16.7% 2/12 • Number of events 2 • 2 months

Additional Information

Dr. Michael Scheeringa

Tulane University

Phone: 5049882167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place