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NCT06573970 · ClinicalTrials.gov registry record · Phase 4
Atomoxetine and Executive Function in PTSD
A Phase 4 study, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
NCT06573970: Recruiting Phase 4 study, sponsored by VA Office of Research and Development.
NCT06573970 is a Phase 4 study that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 160 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06573970, a Phase 4 study, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
Study Summary
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. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans wit
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Atomoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2029-09-28 |
| Phase | Phase 4 |
What NCT06573970 shows while recruiting
NCT06573970 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06573970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06573970 about?
NCT06573970 is a clinical study titled "Atomoxetine and Executive Function in PTSD". 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. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicat...
What is the current status of trial NCT06573970?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2026-04-01. Estimated completion is 2029-09-28.
What interventions are being tested in trial NCT06573970?
The interventions under investigation include: Placebo (DRUG), Atomoxetine (DRUG).
Who is sponsoring clinical trial NCT06573970?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06573970's enrollment target sits among peer trials
160 507th of 2000 higher than 1,485 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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