Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorder |
Drug: Modafinil |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD |
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: Change in CAPS from baseline to 4 weeks ] [ Designated as safety issue: No ]The CAPS is the gold standard measure of PTSD symptoms
- eye-gaze tracking to facial stimuli [ Time Frame: change in eye-gaze tracking from baseline to 4 weeks ] [ Designated as safety issue: No ]a measure of attentional bias
- Modified Stroop [ Time Frame: Change in Modified Stroop from baseline to 4 weeks ] [ Designated as safety issue: No ]a measure of attentional bias
- event related potentials [ Time Frame: Change in P50 from baseline to 4 weeks ] [ Designated as safety issue: No ]P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: modafinil
Study participants randomized to the active arm of the study will take modafinil 100mg 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.
Other Name: Provigil
|
|
Placebo Comparator: Sugar Pill
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.
Other Name: Provigil
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Tim A Kimbrell, MD | 501-257-1084 | timothy.kimbrell@va.gov |
| Contact: Jeffry M Pyne, MD | 501-257-1983 | jeffrey.pyne@va.gov |
| United States, Arkansas | |
| CAVHS Eugene Towbin VA Medical Center | Recruiting |
| North Little Rock, Arkansas, United States, 72114 | |
| Contact: Susan M Jegley, LMSW 501-257-1731 susan.jegley@va.gov | |
| Principal Investigator: Tim A Kimbrell, MD | |
| Sub-Investigator: Jeffrey M Pyne, MD | |
| Principal Investigator: | Tim A Kimbrell, MD | Central Arkansas VA Healthcare System |
More Information
No publications provided
| Responsible Party: | Timothy Kimbrell, Staff Physician; Associate Professor, Biomedical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01726088 History of Changes |
| Other Study ID Numbers: | CAVHS209470-1, 5P20RR020146-09, 8 P20 GM103425-09 |
| Study First Received: | August 3, 2012 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Biomedical Research Foundation:
|
Modafinil p50 Attentional Bias |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Modafinil Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013