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Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

Primary Purpose

Posttraumatic Stress Disorder

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Modafinil

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Modafinil, p50, Attentional Bias

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

CAVHS Eugene Towbin VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

modafinil

Sugar Pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)

The CAPS is the gold standard measure of PTSD symptoms

Secondary Outcome Measures

eye-gaze tracking to facial stimuli

a measure of attentional bias

Modified Stroop

a measure of attentional bias

event related potentials

P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs

Full Information

NCT ID

NCT01726088

First Posted

August 3, 2012

Last Updated

November 9, 2012

Sponsor

Biomedical Research Foundation

Collaborators

National Center for Research Resources (NCRR), National Institute of General Medical Sciences (NIGMS)

1. Study Identification

Unique Protocol Identification Number

NCT01726088

Brief Title

Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

Official Title

A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Biomedical Research Foundation

Collaborators

National Center for Research Resources (NCRR), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

Modafinil, p50, Attentional Bias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

modafinil

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Modafinil

Other Intervention Name(s)

Provigil

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinician Administered PTSD Scale (CAPS)

Description

The CAPS is the gold standard measure of PTSD symptoms

Time Frame

Change in CAPS from baseline to 4 weeks

Secondary Outcome Measure Information:

Title

eye-gaze tracking to facial stimuli

Description

a measure of attentional bias

Time Frame

change in eye-gaze tracking from baseline to 4 weeks

Title

Modified Stroop

Description

a measure of attentional bias

Time Frame

Change in Modified Stroop from baseline to 4 weeks

Title

event related potentials

Description

P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs

Time Frame

Change in P50 from baseline to 4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tim A Kimbrell, MD

Phone

501-257-1084

timothy.kimbrell@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffry M Pyne, MD

Phone

501-257-1983

jeffrey.pyne@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim A Kimbrell, MD

Organizational Affiliation

Central Arkansas VA Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

CAVHS Eugene Towbin VA Medical Center

City

North Little Rock

State/Province

Arkansas

ZIP/Postal Code

72114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susan M Jegley, LMSW

Phone

501-257-1731

susan.jegley@va.gov

First Name & Middle Initial & Last Name & Degree

Tim A Kimbrell, MD

First Name & Middle Initial & Last Name & Degree

Jeffrey M Pyne, MD

12. IPD Sharing Statement

Learn more about this trial

Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

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