Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726088
• Other study ID #: CAVHS209470-1
• Secondary ID: 5P20RR020146-098
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 3, 2012
• Last updated: November 9, 2012
• Start date: August 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2012
• Source: Biomedical Research Foundation
• Contact: Tim A Kimbrell, MD
• Phone: 501-257-1084
• Email: timothy.kimbrell[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	CAVHS Eugene Towbin VA Medical Center	North Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Biomedical Research Foundation	National Center for Research Resources (NCRR), National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	The CAPS is the gold standard measure of PTSD symptoms	Change in CAPS from baseline to 4 weeks	No
Secondary	eye-gaze tracking to facial stimuli	a measure of attentional bias	change in eye-gaze tracking from baseline to 4 weeks	No
Secondary	Modified Stroop	a measure of attentional bias	Change in Modified Stroop from baseline to 4 weeks	No
Secondary	event related potentials	P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs	Change in P50 from baseline to 4 weeks	No