Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)
NCT ID: NCT01726088
Last Updated: 2012-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2012-08-31
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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modafinil
Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks.
Modafinil
we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
Sugar Pill
Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks.
Modafinil
we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
Interventions
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Modafinil
we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
MALE
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
Biomedical Research Foundation
OTHER
Responsible Party
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Timothy Kimbrell
Staff Physician; Associate Professor
Principal Investigators
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Tim A Kimbrell, MD
Role: PRINCIPAL_INVESTIGATOR
Central Arkansas VA Healthcare System
Locations
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CAVHS Eugene Towbin VA Medical Center
North Little Rock, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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Susan M Jegley, LMSW
Role: primary
Other Identifiers
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