Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biomedical Research Foundation
• Collaborators: National Center for Research Resources (NCRR); National Institute of General Medical Sciences (NIGMS)
• Treatments: Armodafinil; Modafinil

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