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Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression

Posttraumatic Stress Disorder Clinical Trial

Official title:
Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression

Clinical Trial 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.

Clinical Trial Description

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 stimuli post-treatment. Specifically, greater degrees of activation of left hemispheric brain structures are anticipated in post-treatment fMRI scans.

Plan: Patients with PTSD-associated impulsive aggression will undergo an eight-week course of treatment with phenytoin or CBT. Treatment-related changes in impulsive-aggressive acts will be correlated with changes in brain activation comparing pre- and post-treatment fMRI scans utilizing a standardized Go-No Go task which has been used in the study of impulsive aggressive individuals. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00333931
Study type Interventional
Source VA Medical Center, Houston
Contact Lisa A Miller, MD
Phone 7137911414
Email Lisa.Miller@va.gov
Status Recruiting
Phase N/A
Start date June 2006
View Details
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