Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Recruitment status was Recruiting
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.
Posttraumatic Stress Disorder
Behavioral: Cognitive Behavioral Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression|
- change in impulsive aggressive acts measured by OAS-M
- 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
|Study Start Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333931
|Contact: Lisa A Miller, MD||7137911414 ext 6021||Lisa.Miller@va.gov|
|United States, Texas|
|Veterans Affairs Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Brenda Schubert 713-791-1414 ext 5995 firstname.lastname@example.org|
|Study Director:||Thomas A Kent, MD||Veterans Affairs Medical Center-Houston|