Phase 4
N=44
Atomoxetine in Veterans With Comorbid ADHD/PTSD
Post Traumatic Stress Disorder · Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02287038 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999) — 75.12; 68.56; 67.79; 72.80 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine 80 MG (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999) |
75.12; 68.56; 67.79; 72.80 | — |
| PRIMARY The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006) |
33.61; 36.51; 43.51; 37.23 | — |
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
Data sourced from ClinicalTrials.gov (NCT02287038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.