Trial Outcomes & Findings for Imaginal Exposure & D-Cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD) (NCT NCT00875342)

NCT ID: NCT00875342

Last Updated: 2021-08-16

Results Overview

Clinician Administered PTSD Scale (CAPS). Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: Immediately after the intervention, an average of 6 months
• Results posted on: 2021-08-16

Participant Flow

Participant milestones

Measure	D-cycloserine DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)	Placebo Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
Overall Study STARTED	20	21
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaginal Exposure & D-Cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Measure	D-cycloserine n=20 Participants DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)	Placebo n=21 Participants Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)	Total n=41 Participants Total of all reporting groups
Age, Continuous	44.50 years STANDARD_DEVIATION 11.75 • n=5 Participants	40.71 years STANDARD_DEVIATION 9.83 • n=7 Participants	42.56 years STANDARD_DEVIATION 10.84 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
CAPS	97.20 units on a scale STANDARD_DEVIATION 17.36 • n=5 Participants	97.43 units on a scale STANDARD_DEVIATION 17.37 • n=7 Participants	97.31 units on a scale STANDARD_DEVIATION 17.15 • n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the intervention, an average of 6 months

Clinician Administered PTSD Scale (CAPS). Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms).

Outcome measures

Measure	D-cycloserine n=13 Participants DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)	Placebo n=14 Participants Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
Symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale (CAPS)	32.31 units on a scale Standard Deviation 32.31	26.93 units on a scale Standard Deviation 25.06

Adverse Events

D-cycloserine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Program director

Weil Cornell Medical College

Phone: 212 821 0783

Email: jdifede@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place