Trial record 69 of 120 for:    CYCLOSERINE OR SEROMYCIN

Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855153
Recruitment Status : Withdrawn (Investigator was not able to maintain IRB approval. Study never accrued subjects.)
First Posted : March 4, 2009
Last Update Posted : December 20, 2011
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

Brief Summary:

The purpose of this pilot study is to begin the examination of the feasibility of using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) in the management of posttraumatic psychological symptoms in burned OIF/OEF military combatants.

The purpose of a feasibility study is to determine if there is clinical utility in this proposed treatment and to establish effective and safe treatment procedures. Given current literature, the following hypotheses are generated:

Hypothesis 1: Virtual Reality Exposure and D-Cycloserine medication (VRE + DCS learning pill) will result in clinically meaningful PTSD symptom reduction.

  1. SMs will attain scores that are lower than initial measures for symptoms of PTSD
  2. By the completion of VRE, Ss will attain scores in the sub-clinical range for measures of clinical depression Hypothesis 2: SMs will report greater life satisfaction following completion of VR+DCS treatment, as measured by scores on the Quality of Life Inventory (QOLI) when compared to pre-treatment scores

Condition or disease Intervention/treatment Phase
Psychological Trauma Other: VR (Virtual reality) Drug: D-Cycloserine Not Applicable

Detailed Description:

The purpose of this study is to establish systematic observations about the feasibility of using gradual exposure virtual reality treatment and D-Cycloserine (VRE + DCS) with service members receiving medical care for burns attained during combat. The rational for this study comes from the need to establish with this population, when and how VRE + DCS might be delivered in a safe and systematic fashion. This would be done in preparation for the potential of a future controlled study to address the efficacy of VRE + DCS in comparison to each component and control group.

This study seeks to establish methods of applying VRE + DCS in relation to medical viability as an attempt to clarify at what stage of medical care a service member is able to give informed consent, follow the proscribed instructions, and participate in VRE+ DCS process to include reasonable attention and capacity for immersion. Other areas that will be examined include medication suitability, expected course of medical treatment that would allow for reasonable completion of twelve sessions within twenty weeks, and assessed stability in social support.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) for Treatment of Combat Related Psychological Trauma in Burn Service Members
Study Start Date : May 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: treatment
Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment
Other: VR (Virtual reality)
VR stimulation of combat scenarios utilized as the exposure therapy tool.
Other Name: Iraq world II

Drug: D-Cycloserine
50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment
Other Name: DCS

Primary Outcome Measures :
  1. Reduction in PTSD symptoms for burn patients and improve perceived life satifaction. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • You are an active duty military male or female service member 18-45 years old and able to participate for duration of care (estimated 12 weeks for initial examination to completion of treatment)
  • You have a diagnosis of Post Traumatic Stress Disorder (PTSD) based on a structured clinical interview
  • You have a score of greater than 40 on the Clinician Administered PTSD Scale (CAPS)

Exclusion Criteria:

  • Psychotic disorders such as schizophrenia, bipolar affective disorder, or history of disruptive non-compliant behaviors
  • Borderline intellectual functioning and attention memory problems as identified by standard USAISR neuropsychological screenings;
  • Major neurological or major medical difficulties, to include epilepsy/seizures or significant cardiovascular conditions such as heart or blood problems that would be dysregulated by increased anxiety exposure;
  • Dependent on drugs based upon screening, self-report or medical record;
  • Motion sickness as seen on the VR assessment trial.
  • Subjects screened with CAPS scores 44 or lower at pre-treatment assessment.
  • Women who are pregnant or breast feeding.
  • Unhealed uncovered wounds on face that would be a significant discomfort or infection risk
  • Open uncovered wound to hands or face that the doctor sees at being a moderate or greater risk for treatment complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855153

United States, Texas
US Army Institute of Surgical Research
Ft Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Principal Investigator: Kathryn M Gaylord, RN, PhD US Army Institute of Surgical Research

Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00855153     History of Changes
Other Study ID Numbers: H-09-012
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by United States Army Institute of Surgical Research:
virtual reality exposure
Combat related psychological trauma in burned servicemembers

Additional relevant MeSH terms:
Wounds and Injuries
Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action