NCT00333931

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
Last Updated

June 6, 2006

Status Verified

June 1, 2006

First QC Date

June 2, 2006

Last Update Submit

June 2, 2006

Conditions

Impulsive AggressionPosttraumatic Stress Disorder

Keywords

Impulsive AggressionPosttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • change in impulsive aggressive acts measured by OAS-M

Secondary Outcomes (3)

  • 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

Interventions

PhenytoinDRUG
Cognitive Behavioral TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

PhenytoinCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thomas A Kent, MD

    Veterans Affairs Medical Center-Houston

    STUDY DIRECTOR

Central Study Contacts

Lisa A Miller, MD

CONTACT

7137911414Lisa.Miller@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

June 1, 2006

Last Updated

June 6, 2006

Record last verified: 2006-06

Locations

US(1)