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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
Information provided by:

Study Description
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 aggression with either phenytoin or cognitive behavioral therapy.

Condition or disease Intervention/treatment
Impulsive Aggression Posttraumatic Stress Disorder Drug: Phenytoin Behavioral: Cognitive Behavioral Therapy

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 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Study Start Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Phenytoin
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. change in impulsive aggressive acts measured by OAS-M

Secondary Outcome Measures :
  1. change in regional brain activation as measured by FMRI
  2. change in PTSD symptoms as measured by CAPS
  3. change in depression symptoms as measured by BDI

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

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    brenda.schubert@va.gov   
Sponsors and Collaborators
VA Medical Center, Houston
Dr. Thomas A. Kent
Dr. Stacey Holmes
Dr. Su Bailey
Dr. Mark Kunik
Dr. Melinda Stanley
Study Director: Thomas A Kent, MD Veterans Affairs Medical Center-Houston
More Information

ClinicalTrials.gov Identifier: NCT00333931     History of Changes
Other Study ID Numbers: IRB # 18342
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: June 6, 2006
Last Verified: June 2006

Keywords provided by VA Medical Center, Houston:
Impulsive Aggression
Posttraumatic Stress Disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers