Overview
Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Michael E. DeBakey VA Medical Center
VA Medical Center, HoustonCollaborators:
Dr. Mark Kunik
Dr. Melinda Stanley
Dr. Stacey Holmes
Dr. Su Bailey
Dr. Thomas A. KentTreatments:
Phenytoin
Criteria
Inclusion Criteria:- 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 Criteria:
- 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).