Status:
UNKNOWN
Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Lead Sponsor:
Michael E. DeBakey VA Medical Center
Collaborating Sponsors:
Dr. Thomas A. Kent
Dr. Stacey Holmes
Conditions:
Impulsive Aggression
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Detailed 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 behav...
Eligibility Criteria
Inclusion
- \- Inclusion Criteria for both groups will be right-handed adult combat veterans over the age of 18 who meet criteria for PTSD via Structured Clinical Interview (SCID-I, First, 2002) and Impulsive Aggression as the primary diagnoses. To be included in the study with a designation of Impulsive Aggression, patients must have committed at least three aggressive acts over the preceding three months meeting criteria for impulsive aggressive acts by Impulsive/Premeditated Aggression Scales (IPAS) criteria (Stanford et al 2003) based on a semi-structured interview of the patient and his/her significant other. An impulsive aggressive act is defined as a hair-trigger, non-premeditated response to a stimulus that results in an immediate aggressive act or an agitated state that culminates in an aggressive act, which is clearly disproportionate to the triggering stimulus. Inclusion criteria for both groups also includes the availability for participation of a significant other who can participate in the study. The significant other will need to accompany the study participant to the initial assessment interview and complete measures of aggressive acts which have been committed by the study participants in the three months prior to the start of the study, and aggressive acts during the previous two weeks at two-week interval follow-up visits throughout the eight-week treatment period.
Exclusion
- Exclusion Criteria for both groups will include exclusion criteria for MRI scanning, and known claustrophobia requiring sedation in the past during MRI scanning. MRI exclusion criteria will include metallic implants, implanted devices of any kind, such as a cardiac pacemaker, cardiac defibrillator, insulin pump, vagal nerve stimulator, cochlear implant, metallic splinters in the eye, ferromagnetic clips or metal in the head or brain (as from previous injury or head/brain surgery including brain aneurysm clipping), lead wires of any kind, clips or stints anywhere in the body, such as clips for arterial aneurysm clipping, stints in cardiac arteries or other arteries anywhere in the body, prosthetic heart valves, stapedial implants of any kind (implants in the inner ear).
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00333931
Start Date
June 1 2006
Last Update
June 6 2006
Active Locations (1)
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1
Veterans Affairs Medical Center
Houston, Texas, United States, 77030