Could a common ADHD drug sharpen focus and boost quality of life for veterans with PTSD?
NCT ID NCT06573970
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests whether atomoxetine, a non-addictive ADHD medication, can improve attention, thinking skills, and quality of life in 160 veterans with PTSD who also have attention problems. Participants will receive either atomoxetine or a placebo for 12 weeks. The goal is to see if treating attention deficits helps veterans respond better to PTSD care and feel better day-to-day.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Veterans ages 18 to 75 with PTSD and AD (CAPS \> 35 for age 18 to 64, CAPS \> 25 for age 65 to 75; CAARS-S:S \> 60) * The cut-score of 25 used for participants age 65 to 75 because lower cut-score has been recommended for older Veterans (Yeager and Magruder, 2014) * ADHD has been recognized as a neurobehavioral impairment in executive function (Brown, 2008) * Veterans with PTSD at this age range are suited for this study because statistically they have fewer confounding variables for this clinical trial, including medical conditions such as hypertension or glaucoma and cognitive impairments such as dementia * Physical health good enough to be able to participate in the study * Competent to give informed consent Exclusion Criteria: * Age younger than 18 or greater than 75 * Age becomes the main risk factor for major neurocognitive disorder, especially after 75 (Sousa et al, 2020) * Known sensitivity to ATX * Presence of disorders that could conceivably be exacerbated by atomoxetine * specifically, narrow angle closure glaucoma, urinary outflow obstruction, hypertension, and neurological disorders, particularly tics and Tourette's syndrome, or a history of epilepsy or seizures * Subjects with major traumatic brain injury (TBI) determined by Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI ID) * However, mild TBI, assessed with OSU-TBI ID and review of record will be allowed to participate in this trial * Use of concomitant medication that could potentially interact with atomoxetine including monoamine oxidase inhibitors (MAOI), antihypertensive medication, or any concomitant medication that is a cytochrome 2D6 (CYP2D6) inhibitor, such as paroxetine, venlafaxine, fluoxetine, because atomoxetine's elimination involves the CYP2D6 system * Subjects who are currently taking psycho-stimulants, other NRIs such as duloxetine, and venlafaxine will be excluded * However, the investigators will allow subjects who stopped the psycho-stimulant or other NRI or other SSRIs 2 weeks prior to the start of the trial * Subjects receiving active ongoing therapy with good response at the point of recruitment * The project will allow approved standard therapies, including psycho- or/and pharmacotherapies be continued with the condition that the subjects continue to present with PTSD symptoms severe enough to meet the inclusion criteria * An active or lifetime major mental health diagnosis as determined by DSM-5 major psychiatric disorders, including: * schizophrenia * schizoaffective disorder * psychotic disorder not otherwise specified * bipolar I disorder, bipolar II disorder * bipolar disorder not otherwise specified * The project will allow the presence of depressive disorders if the depressive episodes are secondary to PTSD * Current substance use disorders: * DSM-5 alcohol * marijuana * and/or other drug use disorders in the last 3 months * Mild alcohol and marijuana use which does not meet the criteria for mild use disorder, such as occasional or recreational use will be permitted on a case by case basis * Females who are pregnant or desired to become pregnant during the clinical trial period * Urine pregnancy tests will be performed at each of the visits, including prior to, during, and after the clinical trial * Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITINGCharleston, South Carolina, 29401-5703, United States