Atomoxetine in Veterans With Comorbid ADHD/PTSD
Condition: Post Traumatic Stress Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Stress Disorders, Traumatic; Attention Deficit Disorder with Hyperactivity; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The current available treatments for PTSD are not fully effective for cognitive symptoms of
      PTSD and have high drop-out and poor engagement, two factors found to be most indicative of
      overall return to functioning for patients with PTSD. The proposed study directly addresses
      this knowledge gap by conducting a pilot, fixed-dose, randomized, double-blind,
      placebo-controlled, and cross-over trial using atomoxetine (ATX) as an add-on medication to
      other therapies to testing the efficacy of ATX in reducing ADHD cognitive symptoms among
      veterans with comorbid ADHD/PTSD. Successful completion of this pilot clinical trial may
      build a platform for future large scale double-blind, placebo-controlled studies using either
      atomoxetine or other cognitive enhancing medications.
    

Detailed description: 
      Combat Veterans with posttraumatic stress disorder (PTSD) often show cognitive impairments in
      attention, working memory, executive functions, and inhibitory control, a cluster of symptoms
      resembling symptoms of ADHD. The presence of comorbid ADHD cognitive symptoms is often
      associated with greater PTSD clinical severity and poorer treatment outcomes. While
      treatments for the avoidance, arousal, and re-experiencing symptoms associated with PTSD for
      military personnel are readily available, substantial gaps exist in the treatment of the
      cognitive deficits associated with PTSD. As a result, untreated co-occurring ADHD cognitive
      symptoms in PTSD may have severe negative impacts on patients' functional recovery, treatment
      outcome, and quality of life. The proposed study directly addresses this knowledge gap by
      testing the feasibility and preliminary efficacy of atomoxetine (ATX) in treatment of ADHD
      cognitive symptoms among those with comorbid ADHD/PTSD. This is a small prospective, 10-week,
      fixed-dose, randomized, double-blind, placebo-controlled, and cross-over trial of ATX as an
      add-on medication to other therapies in Veterans with comorbid ADHD/PTSD. Primary outcome
      measures will be ADHD cognitive symptom reduction and quality of life improvement as measured
      by the Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S) and the Adult ADHD
      Quality of Life-29 (AAQoL-29). Secondary outcome measures will be PTSD and depressive
      symptoms reduction as measured by the Clinician Administered PTSD Scale (CAPS), the Hamilton
      Depression Scale (HAM-D). In addition to subjective measures, the response inhibition task
      Go/NoGo (GNG) will be used as objective assessments to measure ATX treatment outcomes. The
      proposed work is innovative; it applies novel therapeutic agent to treat cognitive symptoms
      in PTSD. To our knowledge, this is the first study to apply a SNRI to address an often
      overlooked PTSD-cognitive deficit. This study is directly responsive to the mission of
      RR&D-SPiRE "to maximize functional recovery" of cognitive function in PTSD. The outcome of
      the proposed research will be significant, because it provides a knowledge base to help
      determine who is at risk for developing treatment resistance among PTSD patients, thereby
      allowing for development of early intervention strategies. More importantly, this clinical
      trial may immediate benefit Veterans by enhancing their cognitive function, reducing ADHD
      symptoms related disability, and further improving quality of life for veterans suffer from
      comorbid ADHD/PTSD.
    

Intervention name(s): Atomoxetine 80 MG
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized and assigned by the study investigator into crossover group 1 (Atomoxetine 80mg at Phase I, then placebo at Phase II) or group 2 (placebo at Phase I, then Atomoxetine at Phase II) with both placebo and medication administered through pharmacy. There was a 1-week interval between the two phases.
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A small prospective, 10-week, fixed-dose, randomized, double-blind, placebo-controlled, and cross-over trial of atomoxetine as an add-on medication to other therapies in Veterans with comorbid ADHD/PTSD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; ADHD; Atomoxetine; Combat Trauma; Cognitive Deficit