Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Biomedical Research Foundation
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Timothy Kimbrell, Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT01726088
First received: August 3, 2012
Last updated: November 9, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by Biomedical Research Foundation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726088

Contacts
Contact: Tim A Kimbrell, MD 501-257-1084 timothy.kimbrell@va.gov
Contact: Jeffry M Pyne, MD 501-257-1983 jeffrey.pyne@va.gov

Locations
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         
Sponsors and Collaborators
Biomedical Research Foundation
Investigators
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
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014