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New treatment option for Posttraumatic Stress Disorder With Attention Defic
Official title Atomoxetine and Executive Function in PTSD
ClinicalTrials.gov ID: NCT06573970
What this study is testing
What is Atomoxetine?
Atomoxetine is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for posttraumatic stress disorder with attention defic.
Also referred to as Strattera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Physical health good enough to be able to participate in the study
You likely can't join if
- 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...
- people with major traumatic brain injury (TBI) determined by Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI ID)
See the full eligibility 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...
- Physical health good enough to be able to participate in the study
- Competent to give informed consent
- 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
- people 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)...
- people who are currently taking psycho-stimulants, other NRIs such as duloxetine, and venlafaxine will be excluded
- However, the investigators will allow people who stopped the psycho-stimulant or other NRI or other SSRIs 2 weeks prior to the start of the trial
- people 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 people continue to present with PTSD symptoms severe enough to meet the inclusion...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.