Status:
COMPLETED
Atomoxetine in Veterans With Comorbid ADHD/PTSD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Post Traumatic Stress Disorder
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
20-60 years
Phase:
PHASE4
Brief 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 t...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02287038
Start Date
October 15 2014
End Date
April 14 2017
Last Update
April 3 2019
Active Locations (1)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799