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Atomoxetine and Executive Function in PTSD

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Site details revisedv10 Show 1 more changeShow less
    • Site details revised
  2. Notable Start date: Feb 2, 2026 to Apr 1, 2026v9
  3. Notable Start date: Nov 17, 2025 to Feb 2, 2026 Site contact updatedv8 Show 1 more changeShow less
    • Site contact updated
  4. Notable Start date: Oct 1, 2025 to Nov 17, 2025 Site contact updatedv7 Show 1 more changeShow less
    • Site contact updated
  5. Notable Start date: Aug 1, 2025 to Oct 1, 2025 Primary completion date: Apr 30, 2029 to Jun 29, 2029 · Completion date: Jul 31, 2029 to Sep 28, 2029v6 Show 2 more changesShow less
    • Primary completion date: Apr 30, 2029 to Jun 29, 2029
    • Completion date: Jul 31, 2029 to Sep 28, 2029
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Jun 1, 2025 to Aug 1, 2025 Primary completion date: Jan 31, 2029 to Apr 30, 2029 · Completion date: May 31, 2029 to Jul 31, 2029v5 Show 2 more changesShow less
    • Primary completion date: Jan 31, 2029 to Apr 30, 2029
    • Completion date: May 31, 2029 to Jul 31, 2029
  2. Notable Start date: Apr 1, 2025 to Jun 1, 2025 Primary completion date: Dec 31, 2028 to Jan 31, 2029 · Completion date: Mar 31, 2029 to May 31, 2029v4 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2028 to Jan 31, 2029
    • Completion date: Mar 31, 2029 to May 31, 2029
  3. Notable Start date: Dec 16, 2024 to Apr 1, 2025 Primary completion date: Jul 31, 2028 to Dec 31, 2028 · Completion date: Oct 31, 2028 to Mar 31, 2029v3 Show 2 more changesShow less
    • Primary completion date: Jul 31, 2028 to Dec 31, 2028
    • Completion date: Oct 31, 2028 to Mar 31, 2029
  4. Minor Interventions: Atomoxetine (Drug) to Atomoxetine (Drug), Placebo (Drug) Secondary endpoints revised (2)v2 Show 1 more changeShow less
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.
Trial Details
NCT Number NCT06573970
Lead Sponsor VA Office of Research and Development
Collaborators: Medical University of South Carolina
Conditions Posttraumatic Stress Disorder With Attention Defic
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov