Recruiting
Phase 2
Phase 3

Modafinil

Sponsor:

Biomedical Research Foundation

Code:

NCT01726088

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: Male

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Modafinil

Study Details

Brief 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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT01726088

Start date

Aug, 2012

Status verified date

Nov, 2012

Completion date

May, 2014

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: modafinil

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

placebo comparator: Sugar Pill

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

Interventions

Modafinil

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

Primary outcome measure

  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Change in CAPS from baseline to 4 weeks ]

Central Contacts and Locations

Central contacts

Tim A Kimbrell, MD

501-257-1084timothy.kimbrell@va.gov

Jeffry M Pyne, MD

501-257-1983jeffrey.pyne@va.gov

Locations

CAVHS Eugene Towbin VA Medical Center

Recruiting

North Little Rock, Arkansas, United States, 72114

Contacts

Susan M Jegley, LMSW

501-257-1731susan.jegley@va.gov

Principal Investigator:

Tim A Kimbrell, MD

More Information

Sponsor

Biomedical Research Foundation

Last update posted

Nov 14, 2012

Last verified

Nov, 2012

Keywords

  • Modafinil
  • p50
  • Attentional Bias

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biomedical Research Foundation on 2012-11-14.