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Trial Outcomes & Findings for Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD) (NCT NCT00632632)

NCT ID: NCT00632632

Last Updated: 2015-08-27

Results Overview

Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

6-months follow-up

Results posted on

2015-08-27

Participant Flow

Participant milestones

Participant milestones
Measure
D-Cycloserine (DCS)
D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Placebo
placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Overall Study
STARTED
13
12
Overall Study
COMPLETED
13
9
Overall Study
NOT COMPLETED
0
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
D-Cycloserine (DCS)
n=13 Participants
D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Placebo
n=12 Participants
placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Total
n=25 Participants
Total of all reporting groups
Age, Continuous
47.77 years
STANDARD_DEVIATION 11.92 • n=5 Participants
43.75 years
STANDARD_DEVIATION 8.72 • n=7 Participants
45.84 years
STANDARD_DEVIATION 10.50 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
1 Participants
n=7 Participants
6 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
11 Participants
n=7 Participants
19 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
10 participants
n=5 Participants
11 participants
n=7 Participants
21 participants
n=5 Participants
Race/Ethnicity, Customized
Black
1 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
2 participants
n=5 Participants
1 participants
n=7 Participants
3 participants
n=5 Participants
Region of Enrollment
United States
13 participants
n=5 Participants
12 participants
n=7 Participants
25 participants
n=5 Participants

PRIMARY outcome

Timeframe: Immediately following treatment

Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)

Outcome measures

Outcome measures
Measure
D-Cycloserine (DCS)
n=13 Participants
D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Placebo
n=12 Participants
placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Clinician Administered PTSD Scale(CAPS)
32.38 units on a scale
Standard Deviation 28.55
42.17 units on a scale
Standard Deviation 20.75

PRIMARY outcome

Timeframe: 6-months follow-up

Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)

Outcome measures

Outcome measures
Measure
D-Cycloserine (DCS)
n=13 Participants
D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Placebo
n=12 Participants
placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Clinician Administered PTSD Scale(CAPS)
24.15 units on a scale
Standard Deviation 26.48
45.92 units on a scale
Standard Deviation 25.66

SECONDARY outcome

Timeframe: Immediately following treatment

Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.

Outcome measures

Outcome measures
Measure
D-Cycloserine (DCS)
n=13 Participants
D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Placebo
n=12 Participants
placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)
78 percentage of MDD remission
60 percentage of MDD remission

Adverse Events

D-Cycloserine (DCS)

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

JoAn Difede, PhD

Weill Cornell Medical College

Phone: 212 746 3079

Results disclosure agreements

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