Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
VR-DCS
Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 27, 2015
CompletedAugust 27, 2015
July 1, 2015
7.9 years
February 29, 2008
June 10, 2015
July 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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). 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)
Immediately following treatment
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). 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)
6-months follow-up
Secondary Outcomes (1)
Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)
Immediately following treatment
Study Arms (2)
D-Cycloserine (DCS)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).
Eligibility Criteria
You may qualify if:
- English-speaking adults
- Between the ages of 18 and 70
- Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
- Diagnosed with PTSD symptoms.
You may not qualify if:
- Presence of current organic mental disorder
- Schizophrenia
- Bipolar disorder
- Depression with psychotic features
- Current substance dependence
- Delusional disorder
- Active suicidal ideation, intent, or plan
- Active homicidal ideation, intent, or plan
- Use of pacemaker
- Medically unstable
- Pregnant or lactating
- A history of severe renal disease
- History of seizures
- Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)
- History of allergic reaction to cycloserine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- JoAn Difede, PhD
- Organization
- Weill Cornell Medical College
Study Officials
- PRINCIPAL INVESTIGATOR
JoAnn Difede, PhD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 11, 2008
Study Start
January 1, 2005
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 27, 2015
Results First Posted
August 27, 2015
Record last verified: 2015-07