Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00875342
Status:
TERMINATED
Last Update Posted:
2021-08-16
First Post:
2009-04-02
Brief Title:
Imaginal Exposure 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:
D-cycloserine Enhanced Imaginal ExposureTherapy for Posttraumatic Stress Disorder PTSD
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial is no longer enrolling due to priority of other non-pharmacologic PTSD trials
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study proposes to evaluate the effects of D-cycloserine DCS combined with cognitive-behavioral treatment with exposure therapy in a sample of patients who developed posttraumatic stress disorder PTSD as a consequence of various traumas eg motor vehicle and accidents burns and other injuries combat World Trade Center attack etc 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 SNP Val66Met predicts treatment response to PTSD
Patients living in areas that are not geographically proximal to the Weill-Cornell Medical Center New York City campus will receive cognitive behavioral therapy using telemedicine videoconferencing technology
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 4 to determine if the BDNF SNP predicts treatment response 5to determine if it is feasible and acceptable to provide imaginal exposure IE therapy for PTSD using videoconferencing technology
Patients living in areas that are not geographically proximal to the Weill-Cornell Medical Center New York City campus will receive cognitive behavioral therapy using telemedicine videoconferencing technology
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 4 to determine if the BDNF SNP predicts treatment response 5to determine if it is feasible and acceptable to provide imaginal exposure IE therapy for PTSD using videoconferencing technology
Detailed Description:
Following an initial assessment evaluating eligibility for the study eligible participants will be randomly assigned to one of two treatment groups imaginal exposure IE plus DCS 100mg or IE plus placebo sugar pill DCS is a broad spectrum antibiotic that has recently been implicated as a cognitive enhancer and may enhance the treatment that occurs The participant assessor and treating clinicians will be blinded to which pill the participant is receiving The dose of medication will need to be taken only on the days of therapy sessions during which the exposure occurs approximately 9 times Both groups will be treated with a standardized cognitive-behavioral exposure therapy protocol utilizing gold-standard treatment consisting of 12-14 weekly individual one-on-one sessions with a highly qualified clinical psychologist Treatment interventions include imaginal exposure graduated in vivo exposure psycho-education relaxation training behavioral activation and cognitive restructuring Assessments will occur prior to treatment following sessions 3 6 and 10 following completion of treatment and 6 months after the conclusion of treatment In addition all participants will be genotyped once for the BDNF SNP Val66Met using a non-invasive saliva sample
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