Posttraumatic Stress DisorderPhase 2/3NCT01726088
Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)
A Phase 2/3 study testing Modafinil in people with Posttraumatic Stress Disorder, run by Biomedical Research Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CAVHS Eugene Towbin VA Medical Center
North Little Rock, Arkansas, 72114
Susan M Jegley, LMSW, 501-257-1731, susan.jegley@va.gov
Tim A Kimbrell, MD
About this study
Official title: A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Modafinil
- Keywords
- Modafinil, p50, Attentional Bias
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called Provigil
we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
| Study group | Role | What they receive |
|---|---|---|
| modafinil | Active comparator | Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks. Receives: 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. Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
The CAPS is the gold standard measure of PTSD symptoms
Measured: Change in CAPS from baseline to 4 weeks
Secondary outcomes (3)
eye-gaze tracking to facial stimuli
a measure of attentional bias
Measured: change in eye-gaze tracking from baseline to 4 weeks
Modified Stroop
a measure of attentional bias
Measured: Change in Modified Stroop from baseline to 4 weeks
event related potentials
P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs
Measured: Change in P50 from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Timothy Kimbrell, Biomedical Research Foundation
- Investigators
- Tim A Kimbrell, MD, Principal investigator, Central Arkansas VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726088
- Sponsor's protocol ID
- CAVHS209470-1
- Other IDs
- 5P20RR020146-09, 8P20GM103425-09
- Status last verified
- Nov 2012
- First submitted
- 3 Aug 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD
- ClinicalTrials.gov ID
- NCT01726088
- Acronym / sponsor ID
- CAVHS209470-1
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Modafinil, p50, Attentional Bias
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Biomedical Research FoundationUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Institute of General Medical Sciences (NIGMS)
- Study start
- Aug 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modafinil | Active comparator | Drug: ModafinilStudy participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks. |
| Sugar Pill | Placebo comparator | Drug: ModafinilStudy participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilAlso: Provigilwe will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above. | Drug | Sugar Pill, modafinil |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: Change in CAPS from baseline to 4 weeks
The CAPS is the gold standard measure of PTSD symptoms
3 secondary outcomes
eye-gaze tracking to facial stimuli
Time frame: change in eye-gaze tracking from baseline to 4 weeks
Modified Stroop
Time frame: Change in Modified Stroop from baseline to 4 weeks
event related potentials
Time frame: Change in P50 from baseline to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim A Kimbrell, MD principal investigator
Central Arkansas VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Modafinil in people with Posttraumatic Stress Disorder, run by Biomedical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim A Kimbrell, MD (501-257-1084, timothy.kimbrell@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: Change in CAPS from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.