Expired Study
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Charleston, South Carolina 29401


Purpose:

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. Successful completion of this pilot clinical trial may build a platform for future large scale double-blind, placebo-controlled studies using either atomoxetine or psycho-stimulants or other cognitive enhancing medications. The response inhibition related measurements are sensitive to psychotropic medications. Therefore it is advantageous for us to use GNG and Stop Signal approaches to investigate individual treatments response in the investigators' future research. The investigators believe GNG and Stop signal approaches together with pharmacogenetic approach will provide valuable information to direct future individualized medicine.


Study summary:

PTSD is a debilitating disorder that is common among Veterans returning from Iraq and Afghanistan (OIF/OEF) due to the high risk of exposure to combat and other trauma. Recently, emerging evidence suggest a strong link between PTSD and ADHD. The co-occurring ADHD symptoms are likely to reflect the impairment in cognitive function, which often expressed as reduced attention span, concentration difficulties, impaired decision-making abilities, and memory problems (LaGarde et al, 2010). Co-occurring ADHD cognitive impairments add another layer of complexity to the disease process and pose more severe impairments in daily function. 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. Further, ADHD cognitive symptoms are associated with poorer patient attendance to medical appointments, poorer medication compliance and increased risk for psychotherapy resistance and medication abuse or diversion (Kolar et al., 2008). Consistent attendance is the best predictor of patient functional recovery from PTSD (Tarrier et al., 2000). Subsequently, untreated co-occurring ADHD cognitive symptoms that increase the risk for problems in patients' PTSD treatment engagement, PTSD treatment responses, functional impairment, and quality of life have tremendous negative impact on treatment outcome. However, in so far, studies have not examined the impact that treating ADHD cognitive symptoms have on PTSD treatment engagement, outcome, and functional recovery. 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. The investigators' research 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 will provide a knowledge base to help determine who is at risk for developing problems with treatment engagement among PTSD patients, thereby allowing for development of early intervention strategies before drop-out. More importantly, the new knowledge may lead to discovering new targets for novel and more effective treatments for PTSD. This novel clinical trial may have immediate benefit to Veterans by enhancing their cognitive function, reducing ADHD symptom related disabilities and further improving quality of life for Veterans with comorbid ADHD/PTSD.


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


NCT ID:

NCT02287038


Primary Contact:

Principal Investigator
Zhewu Wang, MD
Ralph H. Johnson VA Medical Center, Charleston, SC


Backup Contact:

N/A


Location Contact:

Charleston, South Carolina 29401
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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