Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Modafinil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OEF/OIF Veteran with a history of deploying to Afghanistan or Iraq right-handed male 20-60 years of age meets Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for PTSD competent to give informed consent access to a telephone stable psychotropic medication regimen for a minimum of four weeks prior to enrollment able and willing to complete the required schedule of evaluations (Baseline in person, 1 week by phone, 2 week in person, 4 week in person) Exclusion Criteria: diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder current substance abuse or dependence history of seizure disorder or severe traumatic brain injury history of attempted suicide within the previous two years or active suicidal ideation within the past month currently taking benzodiazepines except for bedtime dosing only currently taking stimulant medication known allergic reaction to modafinil or currently taking medication that may have altered metabolism if taken with modafinil: Tricyclic antidepressants (amitriptyline; nortriptyline; desipramine; imipramine; CNS stimulants (amphetamine; d-ampthetamine; atomoxetine); Carbamazepine; Phenytoin; Phenobarbitol; Rifampin; Ketaconazole; MAO Inhibitors (isoniazid; selegiline); Warfarin; Diazepam; Mephenytoin; Cyclosporine; Theophylline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modafinil<br>Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks. | Drug: Modafinil<br>* we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.<br>* Other names: Provigil;|
| Placebo Comparator: Sugar Pill<br>Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks. | Drug: Modafinil<br>* we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.<br>* Other names: Provigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) | The CAPS is the gold standard measure of PTSD symptoms | Change in CAPS from baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eye-gaze tracking to facial stimuli | a measure of attentional bias | change in eye-gaze tracking from baseline to 4 weeks | 
| Modified Stroop | a measure of attentional bias | 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 | Change in P50 from baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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p50, Modafinil, Attentional Bias