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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D-Cycloserine
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring World Trade Center Victims, Iraq War Veterans, PTSD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. English-speaking adults
  2. Between the ages of 18 and 70
  3. Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
  4. Diagnosed with PTSD symptoms.

Exclusion Criteria:

  1. Presence of current organic mental disorder
  2. Schizophrenia
  3. Bipolar disorder
  4. Depression with psychotic features
  5. Current substance dependence
  6. Delusional disorder
  7. Active suicidal ideation, intent, or plan
  8. Active homicidal ideation, intent, or plan
  9. Use of pacemaker
  10. Medically unstable
  11. Pregnant or lactating
  12. A history of severe renal disease
  13. History of seizures
  14. Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)
  15. History of allergic reaction to cycloserine.

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D-Cycloserine (DCS)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
February 29, 2008
Last Updated
July 29, 2015
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00632632
Brief Title
Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
Acronym
VR-DCS
Official Title
Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Participants with 9/11-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
World Trade Center Victims, Iraq War Veterans, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-Cycloserine (DCS)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale(CAPS)
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
Title
Clinician Administered PTSD Scale(CAPS)
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
Secondary Outcome Measure Information:
Title
Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnn Difede, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.patss.com
Description
Related Info

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

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