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Trial record 65 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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

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ClinicalTrials.gov Identifier: NCT00632632
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : August 27, 2015
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Interventions Drug: D-Cycloserine
Other: Placebo
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-Cycloserine (DCS) Placebo
Hide Arm/Group Description 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: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Period Title: Overall Study
Started 13 12
Completed 13 9
Not Completed 0 3
Arm/Group Title D-Cycloserine (DCS) Placebo Total
Hide Arm/Group Description 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: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times). Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
47.77  (11.92) 43.75  (8.72) 45.84  (10.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
5
  38.5%
1
   8.3%
6
  24.0%
Male
8
  61.5%
11
  91.7%
19
  76.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Caucasian 10 11 21
Black 1 0 1
Hispanic 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 12 participants 25 participants
13 12 25
1.Primary Outcome
Title Clinician Administered PTSD Scale(CAPS)
Hide Description

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)

Time Frame Immediately following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Cycloserine (DCS) Placebo
Hide Arm/Group Description:
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: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.38  (28.55) 42.17  (20.75)
2.Primary Outcome
Title Clinician Administered PTSD Scale(CAPS)
Hide Description

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)

Time Frame 6-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Cycloserine (DCS) Placebo
Hide Arm/Group Description:
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: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.15  (26.48) 45.92  (25.66)
3.Secondary Outcome
Title Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)
Hide Description Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.
Time Frame Immediately following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Cycloserine (DCS) Placebo
Hide Arm/Group Description:
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: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of MDD remission
78 60
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-Cycloserine (DCS) Placebo
Hide Arm/Group Description 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: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
All-Cause Mortality
D-Cycloserine (DCS) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
D-Cycloserine (DCS) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-Cycloserine (DCS) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: JoAn Difede, PhD
Organization: Weill Cornell Medical College
Phone: 212 746 3079
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00632632     History of Changes
Obsolete Identifiers: NCT00161499
Other Study ID Numbers: 0411007625
First Submitted: February 29, 2008
First Posted: March 11, 2008
Results First Submitted: June 10, 2015
Results First Posted: August 27, 2015
Last Update Posted: August 27, 2015