Back to search results

Atomoxetine for Executive Function in PTSD with Attention Deficits

This study is looking at whether atomoxetine, a medication used for attention deficit hyperactivity disorder (ADHD) and executive dysfunction, can help Veterans who have both Posttraumatic Stress Disorder (PTSD) and attention deficits. We know that attention problems often make PTSD worse and can make treatments less effective. This study aims to see if atomoxetine can improve executive function (skills like planning and problem-solving) in these Veterans. Participants will receive either atomoxetine (40mg to 80mg) or a placebo (a pill with no active medicine) for 12 weeks. Researchers will measure changes in executive function using a tool called the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) to see if atomoxetine is more effective than placebo. The study also aims to see if atomoxetine improves quality of life and daily functioning. We are looking to enroll 160 Veterans aged 18 to 75.

Study design
This is a 12-week, randomized, double-blind, placebo-controlled study involving 160 participants. This means participants will be randomly assigned to receive either atomoxetine or a placebo, and neither they nor the study staff will know which they are receiving.
What's involved
Participants will receive blinded medication at the start of the study and at weeks 2, 4, 8, and 12. The primary outcome measure, BRIEF-A, will be measured at 15 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 15 minutes, and the treatment period is 12 weeks. The record does not specify follow-up beyond the 12-week treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06573970

Atomoxetine and Executive Function in PTSD

Recruiting
PHASE4Ages 18–75InterventionalTreatment
VA Office of Research and Development
~160 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:AtomoxetinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Measured over 15 minutes

Conditions

Posttraumatic Stress Disorder With Attention Defic

Explore related trials

Attention Deficit Hyperactivity DisorderPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Zhewu Wang, MD · PRINCIPAL_INVESTIGATOR · Ralph H. Johnson VA Medical Center, Charleston, SC

Who to contact

Zhewu Wang, MD
[email protected]
(843) 789-7949
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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)

Exclusion

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

What this trial measures

  • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)15 minutes

    The BRIEF-A is a 75-item questionnaire that assesses adult executive functioning and self-regulation. It's suitable for adults ages 18-90 with a wide range of developmental, neurological, psychiatric, and systemic disorders. BRIEF-A uses a 3-point scale to rate items on a frequency basis, with 0 indicating "never", 1 indicating "sometimes", and 2 indicating "often". The raw scores, range from 0 to 150, of each scale are added together to calculate T scores. The higher T scores reflecting greater degree of executive dysfunction and levels of impairment, with scores at or above 65 suggestive of clinical significance.