The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder
|ClinicalTrials.gov Identifier: NCT00917371|
Recruitment Status : Unknown
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : June 10, 2009
Last Update Posted : November 24, 2010
|Condition or disease|
|Attention Deficit Hyperactivity Disorder|
- To examine the efficacy of atomoxetine in improving neuropsychological functioning (CANTAB, Time Perception Tasks) and structural (DSI) and functional (resting fMRI) brain connectivity as the primary efficacy endpoints.
- To examine the efficacy of atomoxetine in reducing ADHD core symptoms and in improving family/social/academic/occupational adjustment and quality of life.
The study design is a randomized open-label, methylphenidate control trial. The sample consists of 60 adults, aged 18-50, with clinical diagnosis of DSM-IV. All participants will be randomly assigned to atomoxetine (n= 30), methylphenidate (n= 15), and clinical visit with psychological counseling (n=15) in a 8-week randomized clinical trial with 3 treatment arms.
The measures included psychiatric interviews (ADHD+SADS), the CGI-ADHD-S, the standardized self-reported questionnaires (the AAQoL, WFIRS-S, and WFIRS-P for social function; ASRS for ADHD symptoms), neuropsychological tests (CANTAB including attention tasks, visual memory, executive functioning, and gambling test; Time Perception Task), and brain imaging (DSI and resting fMRI).
They will be reassessed with safety, ADHD symptoms and social functioning/quality of life at baseline, week 2 (± 5 days), week 4 (± 5 days), and week 8 (± 5 days); neuropsychological tests at baseline, week 4 (± 5 days), and week 8 (± 5 days); and brain imaging studies (DSI and resting-fMRI) at baseline and week 8 (± 5 days). Additionally, blood sample will be collected at baseline for future pharmacogenomic study.
We anticipate that this study will be one of the first to investigate the efficacy of atomoxetine on neuropsychological functioning, and structural and functional brain connectivity in the world. If this research can be carried out, it will be the first project using brain images as assessment tools in a clinical trial among psychiatric patients in psychiatric field in Taiwan.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2011|
|psychological counseling group|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917371
|Contact: Susan Shur-Fen Gau, MD, PhD||+886-2-23123456 ext email@example.com|
|National Taiwan Univeristy Hospital||Recruiting|
|Contact: Susan Shur-Fen Gau, MD, PhD +886-2-23123456 ext 66802 firstname.lastname@example.org|
|Principal Investigator: Susan Shur-Fen Gau, MD, PhD|
|Principal Investigator:||Susan Shur-Fen Gau, MD, PhD||National Taiwan University Hospital & College of Medicine|