Atomoxetine in Veterans With Comorbid ADHD/PTSD

Completed · Phase 4 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT02287038

Run by

VA Office of Research and Development

People needed

44

Starts

2014-10-15

Expected to finish

2017-04-14

Last updated by the study team

2019-04-03

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.