Clinical Trial: Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Brief Summary: The purpose of this study is to identify changes in brain functioning which are related to reduced frequency and/or intensity of impulsive aggressive actions after treatment of PTSD-related impulsive aggression with either phenytoin or cognitive behavioral therapy.
Detailed Summary:
Objective One: One study objective is to evaluate potential effect sizes of phenytoin and cognitive behavioral therapy for PTSD-related impulsive aggression.
Hypothesis: Phenytoin and cognitive behavioral therapy are hypothesized to be effective in the treatment of PTSD-related impulsive aggression based on studies previously outlined.
Plan: Patients enrolled in this pilot study will be randomized to receive an eight-week course of treatment with phenytoin or cognitive behavioral therapy in the Trauma Recovery Program at the Veterans’s Affairs Medical Center in Houston, Texas.
Objective Two: Another study objective is to begin to attempt to delineate potential neural correlates of treatment-related reductions in PTSD-related impulsive aggression.
Hypothesis: Potential neural correlates of treatment-related reduction in intensity and/or severity of impulsive-aggressive acts are hypothesized to include changes in: 1) thalamic activation reflecting more effective thalamic sensory gating, with anticipation of increased activation of the thalamus post-treatment 2) activation of brain regions associated with verbal information processing, with the anticipation of increased activation of these regions post-treatment 3) activation of prefrontal regions, including the anticipation of increased activation of the medial and/or orbital prefrontal cortex post-treatment, 4) amygdalar activation, with the anticipation of decreased activation of the amygdala post-treatment 5) hippocampal activation, with the anticipation of increased activation of the hippocampus post-treatment, and/or, 6) right-left hemispheric dissociation of brain processing of stimuli, with the anticipation of greater degrees of bilaterality of brain processing of
Sponsor: VA Medical Center, Houston
Current Primary Outcome: change in impulsive aggressive acts measured by OAS-M
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change in regional brain activation as measured by FMRI
- change in PTSD symptoms as measured by CAPS
- change in depression symptoms as measured by BDI
Original Secondary Outcome: Same as current
Information By: VA Medical Center, Houston
Dates:
Date Received: June 2, 2006
Date Started: June 2006
Date Completion:
Last Updated: June 2, 2006
Last Verified: June 2006