Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00632632
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2008-02-29
Brief Title:
Virtual Reality D-cycloserine DCS for Posttraumatic Stress Disorder PTSD
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Combined Exposure Therapy and D-Cycloserine vs Placebo for Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-DCS
Brief Summary:
This study proposes to evaluate the effects of D-cycloserine DCS combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder PTSD following either the events of September 11 2001 or military service in the war in Iraq In addition this study hopes to determine whether a common human genetic single nucleotide polymorphism SNP in a growth factor brain derived neurotrophic factor BDNF Val66Met predicts treatment response to PTSD
Overall this study aims 1 to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo 2 to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier as measured by weeks than those administered a placebo 3 to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups and 4 to determine if the BDNF SNP predicts treatment response
Overall this study aims 1 to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo 2 to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier as measured by weeks than those administered a placebo 3 to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups and 4 to determine if the BDNF SNP predicts treatment response
Detailed Description:
Participants with 911-related or military service in the Iraq War-related PTSD are assigned to one of two programs following an initial assessment Both programs include Virtual Reality Exposure Therapy VRET for the treatment of PTSD as well as widely-used standard cognitive-behavioral therapy techniques The VRET is comprised of ten ninety minute sessions which involve mental imagery as well as virtual reality presentations delivered by a special display worn over the head and eyes The virtual reality simulations consist of either images of the World Trade Center and the events of September 11 2001 or multiple scenarios common to military personnel assigned to Iraq One group of participants will receive the medication cycloserine seromycin and one group will receive a placebo drug like a sugar pill Participants take a dose of medication only on the days that they come to the laboratory for the Virtual Reality Exposure VRE sessions and 90 minutes prior to the VRE sessions Some subjects in the study will receive a 100 mg dose of cycloserine and other subjects in the study will receive the placebo sugar pill This will be determined randomly as by the flip of a coin Neither the patient nor the treating clinicians will know which pill that patients are receiving however this arrangement may be changed if medically necessary Patients are briefly assessed for well-being at every session and are reassessed following session three session six and session ten for changes in symptomatology At the completion of treatment and again six months later the principal investigator or one of her associates will reinterview participants and have them complete some questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None