Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: DCS (D-Cycloserine ) + Prolonged Imaginal Exposure; DCS (D-Cycloserine ) + Virtual Reality Exposure; Placebo + Prolonged Imaginal Exposure; Placebo (sugar pill) + Virtual Reality Exposure
Intervention description: 50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure; 50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure; Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure; Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure
Intervention MeSH terms: Cycloserine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The two primary co-aims of this study are
to examine the effects of DCS versus placebo (PLA) augmentation of exposure therapy on PTSD symptoms and
to examine the relative efficacy of virtual reality enhanced exposure therapy (VRE) and exposure therapy (PE) on PTSD symptoms.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Traumatic Event; Trauma Survivor; Exposure Therapy; PTSD DCS; Virtual Reality Exposure; Veteran; Combat-related PTSD

Summary:

      The purpose of this study is to test the differences between four active treatment conditions
      for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy
      (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to
      examine predictors for PTSD and response to treatment in active duty military personnel,
      veterans, and civilians who served in Iraq and Afghanistan.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of OEF-OIF (Operations Enduring Freedom or Iraqi Freedom) Combat Related
             PTSD;

          2. Female participants of childbearing potential must agree to use an effective method of
             birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide)
             during the course of the study, or to remain abstinent from sex, to ensure they do not
             become pregnant during the course of the study;

          3. Ability to provide informed consent and function at an intellectual level sufficient
             to allow accurate completion of all assessment instruments;

          4. Participants must be literate in English;

          5. Patients must be medically healthy and willing to take the study drug;

          6. VRE stimuli available must be consistent with subject's trauma.

        Exclusion Criteria:

          1. Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar
             disorder;

          2. Participation in a clinical trial during the previous 3 months;

          3. Current evidence or history of significant unstable medical illness or organic brain
             impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary,
             gastrointestinal, renal or hepatic impairment;

          4. Patients who in the investigator's judgment pose a current suicidal or homicidal risk;

          5. Alcohol, medication, or illegal substance dependence within the past 90 days;

          6. Treatment with any other concomitant medication with primarily CNS activity, or
             treatment with any medication that the PI judges not acceptable for this study;

          7. history of seizures;

          8. Pregnancy or lactation.