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
Intervention: Atomoxetine 80 MG
Intervention description: 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.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: randomized, double-blind, placebo-controlled, and cross-over trial
Enrollment: 44.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: PTSD; ADHD; Atomoxetine; Combat Trauma; Cognitive Deficit

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans age 20 to 60 with PTSD and significant ADHD symptoms (CAARS-S:S > 65);

          -  Good physical health.

          -  Evidence of combat as defined by:

               -  Trauma exposure sufficient to meet Category A of PTSD criteria (Breslau and
                  Kessler 2001)

        Exclusion Criteria:

          -  Age younger than 20 or greater than 60.

          -  Known sensitivity to ATX

          -  Presence of disorders that could conceivable 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).

          -  Use of concomitant medication that could potentially interact with atomoxetine
             including monoamine oxidase inhibitors (MAOI), antihypertensive medication, or any
             concomitant medication that was a cytochrome 2D6 inhibitor (CYP2D6), since
             atomoxetine's elimination involves the CYP2D6 system.

          -  An active or lifetime major mental health diagnosis as determined by DSM-IV Axis I
             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 presence of depressive disorders if the
             depressive episodes are secondary to PTSD.

          -  Current substance dependence and abuse (within 3 month).

          -  Females who are pregnant.

          -  Suicidal thoughts and behavior. b. Sources of Material