Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
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|ClinicalTrials.gov Identifier: NCT00333931|
Recruitment Status : Unknown
Verified June 2006 by VA Medical Center, Houston.
Recruitment status was: Recruiting
First Posted : June 6, 2006
Last Update Posted : June 6, 2006
|Condition or disease||Intervention/treatment|
|Impulsive Aggression Posttraumatic Stress Disorder||Drug: Phenytoin Behavioral: Cognitive Behavioral Therapy|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression|
|Study Start Date :||June 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 email@example.com|
|Study Director:||Thomas A Kent, MD||Veterans Affairs Medical Center-Houston|