A Phase 2/3 interventional study of Modafinil in Posttraumatic Stress Disorder, sponsored by Biomedical Research Foundation. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-11-14.
Sponsored by Biomedical Research Foundation · Phase 2/3, Interventional, and Treatment
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.
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Biomedical Research Foundation is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks.
Drug: Modafinil
Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks.
Drug: Modafinil
we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
Also known as: Provigil
Clinician Administered PTSD Scale (CAPS)
The CAPS is the gold standard measure of PTSD symptoms
Time frame: Change in CAPS from baseline to 4 weeks
eye-gaze tracking to facial stimuli
a measure of attentional bias
Time frame: change in eye-gaze tracking from baseline to 4 weeks
Modified Stroop
a measure of attentional bias
Time frame: Change in Modified Stroop from baseline to 4 weeks
event related potentials
P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs
Time frame: Change in P50 from baseline to 4 weeks
This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Biomedical Research Foundation