Trial | NCT01726088  Report issue

Title

Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)
A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    modafinil ...

  • Study Participants

    40
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.
Study Started
Aug 31
2012
Primary Completion
May 31
2013
Anticipated
Study Completion
May 31
2014
Anticipated
Last Update
Nov 14
2012
Estimate

Drug Modafinil

we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.

  • Other names: Provigil

modafinil Active Comparator

Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks.

Sugar Pill Placebo Comparator

Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks.

Criteria 

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
No Results Posted