Recruiting

PTSD Treatment

Sponsor:

Michael E. DeBakey VA Medical Center

Code:

NCT00333931

Conditions

Impulsive Aggression

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Phenytoin

Cognitive Behavioral Therapy

Study Details

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.

Conditions

Impulsive Aggression

Posttraumatic Stress Disorder

Study ID

NCT00333931

Start date

Jun, 2006

Status verified date

Jun, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

12 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Phenytoin

Cognitive Behavioral Therapy

Primary outcome measure

  • change in impulsive aggressive acts measured by OAS-M [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Locations

Veterans Affairs Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Michael E. DeBakey VA Medical Center

Last update posted

Jun 6, 2006

Last verified

Jun, 2006

Keywords

  • Impulsive Aggression
  • Posttraumatic Stress Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael E. DeBakey VA Medical Center on 2006-06-06.