Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine if modafinil is more effective than placebo in the treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been deployed to Iraq or Afghanistan.

Clinical Trial Description

There is a high rate of posttraumatic stress disorder (PTSD) in soldiers exposed to combat in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF). Unfortunately, currently available treatments for combat-related PTSD have produced modest treatment gains at best. New treatment strategies that can be directed toward objectively measured correlates of PTSD are urgently needed.

Specific Aims: 1) To determine if there is evidence for the effectiveness and tolerability of adjunctive modafinil in the treatment of combat-related PTSD. We hypothesize that OEF/OIF veterans with PTSD randomized to modafinil 100mg/day for four weeks will experience more improvement in PTSD symptoms than OEF/OIF veterans with PTSD randomized to placebo treatment for four weeks. 2) To determine if PTSD symptom severity is associated with electrophysiological and neuropsychological measures of pre-attention and attention and if these measures change to a greater degree in participants randomized to modafinil versus those randomized to placebo. We hypothesize modafinil treatment will result in greater changes in electrophysiological and neuropsychological measures of pre-attention and attention than placebo treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01726088
Study type	Interventional
Source	Biomedical Research Foundation
Contact	Tim A Kimbrell, MD
Phone	501-257-1084
Email	timothy.kimbrell@va.gov
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	August 2012
Completion date	May 2014

View Details

See also
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	`NCT02720497` - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD	N/A
Completed	`NCT01911585` - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01693978` - Contingency Outcomes in Prolonged Exposure	N/A
Completed	`NCT01469754` - Longitudinal Survey Analysis in Lymphoma Survivors	N/A
Completed	`NCT02362477` - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD	Phase 3
Terminated	`NCT01239173` - Emotional Memory Reactivation in Posttraumatic Stress Disorder	Phase 3