NCT01726088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

August 3, 2012

Last Update Submit

November 9, 2012

Conditions

Posttraumatic Stress Disorder

Keywords

Modafinilp50Attentional Bias

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale (CAPS)

    The CAPS is the gold standard measure of PTSD symptoms

    Change in CAPS from baseline to 4 weeks

Secondary Outcomes (3)

  • eye-gaze tracking to facial stimuli

    change in eye-gaze tracking from baseline to 4 weeks

  • Modified Stroop

    Change in Modified Stroop from baseline to 4 weeks

  • event related potentials

    Change in P50 from baseline to 4 weeks

Study Arms (2)

modafinil

ACTIVE COMPARATOR

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

Drug: Modafinil

Sugar Pill

PLACEBO COMPARATOR

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

Drug: Modafinil

Interventions

ModafinilDRUG

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

Also known as: Provigil
Sugar Pillmodafinil

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAVHS Eugene Towbin VA Medical Center

North Little Rock, Arkansas, 72114, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Tim A Kimbrell, MD

    Central Arkansas VA Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim A Kimbrell, MD

CONTACT

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

Jeffry M Pyne, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician; Associate Professor

Study Record Dates

First Submitted

August 3, 2012

First Posted

November 14, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

US(1)