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

• 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: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

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.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder	Drug: D-Cycloserine; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder
• Study Start Date: January 2005
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: D-Cycloserine (DCS)	Drug: D-Cycloserine; 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)
Placebo Comparator: Placebo	Other: Placebo; 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).

Outcome Measures

Primary Outcome Measures :

1. Clinician Administered PTSD Scale(CAPS) [ Time Frame: Immediately following treatment ]

   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)

2. Clinician Administered PTSD Scale(CAPS) [ Time Frame: 6-months follow-up ]

   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 :

1. Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD) [ Time Frame: Immediately following treatment ]
   Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New York

Weill Cornell Medical College

New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

• Principal Investigator: JoAnn Difede, PhD; Weill Medical College of Cornell University

More Information

Additional Information:

Related Info 

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT00632632
• Obsolete Identifiers: NCT00161499
• Other Study ID Numbers: 0411007625
• First Posted: March 11, 2008
• Results First Posted: August 27, 2015
• Last Update Posted: August 27, 2015
• Last Verified: July 2015

Keywords provided by Weill Medical College of Cornell University:

World Trade Center Victims; Iraq War Veterans; PTSD

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cycloserine; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action