Atomoxetine in Veterans With Comorbid ADHD/PTSD

NCT02287038 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: D1725-PI01BX007080
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post Traumatic Stress Disorder; Attention Deficit Hyperactivity Disorder

Keywords

PTSD; ADHD; Atomoxetine; Combat Trauma; Cognitive Deficit

Outcome Measures

Primary Outcomes (2)

• Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999)

  Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999): The CAARS-S:S is a 26-item questionnaire that assesses symptoms of ADHD in persons aged 18 years or older. T-scores above 65 indicate a likelihood of moderate to severe ADHD symptoms and impairment. The range for the CAARS-S:S is from 0 to 78. A score of 78 would resemble the worst symptoms of ADHD with a score 0 having no symptoms.

  Visit 1, (Day1), Visit 4(Day 36), Visit 7 (Day 71)

• The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006)

  The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006): AAQoL-29 is a 29-item questionnaire designed to assess quality of life and was a secondary efficacy measure in this trial. It is a participant-reported outcome measure used to examine disease specific functional impairments and quality of life for adults with ADHD. The AAQoL is scored as an overall total score, measuring Life Productivity, Psycholofical Health, Relationship, and Life Outlook. Each item is rated by patients on a 5-point Likert scale ranging from "Not at all/Never" (1) to "Extremely/Very Often" (5). To derive overall scores, item scores are transformed to a 0-100-point scale (1=0; 2=25; 3=50; 4=75; 5=100). Then, the item scores are summed up and divided by item count to generate overall scores. The score range from 0 to 100. A higher score indicates greater QoL and better functioning.

  Visit 1 (Day1), 4(Day 36), 7 (Day 71)

Study Arms (2)

Atomoxetine 80mg

ACTIVE COMPARATOR

Atomoxetine (fixed dose of 80mg), a non-stimulant medication, FDA approve for treatment of ADHD. The active drug will be applied in first phase in group one and in second phase in group two

Drug: Atomoxetine 80 MG

Placebo

PLACEBO COMPARATOR

A pharmaceutically inert substance, which will be given to group one in their second phase and group tow in first phase.

Drug: Atomoxetine 80 MG

Interventions

Atomoxetine 80 MG DRUG

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.

Also known as: Strattera

Atomoxetine 80mg; Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (1)

• Wang Z, Zuschlag ZD, Myers US, Hamner M. Atomoxetine in comorbid ADHD/PTSD: A randomized, placebo controlled, pilot, and feasibility study. Depress Anxiety. 2022 Apr;39(4):286-295. doi: 10.1002/da.23248. Epub 2022 Mar 21.

  PMID: 35312136 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Attention Deficit Disorder with Hyperactivity; Cognition Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Zhewu Wang
• Organization: Ralph H. Johnson VA Medical Center

zhewu.wang@va.gov

8437897949

Study Officials

• Zhewu Wang, MD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized, double-blind, placebo-controlled, and cross-over trial
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: November 10, 2014
• Study Start: October 15, 2014
• Primary Completion: March 2, 2017
• Study Completion: April 14, 2017
• Last Updated: April 3, 2019
• Results First Posted: April 3, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)