Posttraumatic Stress Disorder Clinical Trial
Official title:
Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03384706 -
A Comparison of CPT Versus ART Versus WL
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03129204 -
Sensation Awareness Focused Training for Spouses
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Completed |
NCT05113277 -
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Completed |
NCT00644423 -
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT02989987 -
NET for SGBV Survivors in Eastern DR Congo
|
N/A | |
Completed |
NCT02320799 -
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
|
N/A | |
Recruiting |
NCT02293291 -
Thermal Clinic Treatment in Gulf War Illness
|
Phase 1/Phase 2 | |
Completed |
NCT02242136 -
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Completed |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01469754 -
Longitudinal Survey Analysis in Lymphoma Survivors
|
N/A | |
Terminated |
NCT01239173 -
Emotional Memory Reactivation in Posttraumatic Stress Disorder
|
Phase 3 | |
Completed |
NCT02362477 -
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
|
Phase 3 |