CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 156 enrolled
Drug / intervention
D-Cycloserine +3 moredrug
Likely dose
D-Cycloserine 50 mg (5 doses total, one 30 minutes before each VRE session) or Alprazolam 0.25 mg (5 doses total, one 30 minutes before each VRE session)AI-extracted
Key inclusion· 3
  • ✓Meets DSM-IV criteria for PTSD due to Iraq military trauma
  • ✓Speaks English
  • ✓Healthy overall
Key exclusion· 6
  • ✕History of mania, schizophrenia, or other psychoses
  • ✕Suicidal ideation or behavior
  • ✕Current alcohol or drug dependence
  • ✕Pregnant or planning pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00356278
NCT00356278Phase 3Completed
CompareCT.gov

A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD

Emory University·interventional·Posted Jul 25, 2006·Updated Jan 8, 2016

In Brief

A Phase 3 clinical trial evaluating D-Cycloserine, Alprazolam, and 2 other interventions for Stress Disorder, Post Traumatic. Completed, enrolled 156 participants across 1 site.

Detailed Summary

This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Disorder, Post Traumatic
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2006
Enrollment StartSep 1, 2006
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 19.9 years ago

Interventions

D-Cycloserinedrug

D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

Alprazolamdrug

Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

Virtual Reality Exposure Therapybehavioral

VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.

Placebodrug

Placebo will be administered in the same manner as the active drugs.