The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00917371
First received: June 8, 2009
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%), early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high heritability. Pharmacotherapy (methylphenidate and atomoxetine) has been proved to be the most effective treatment for ADHD. Gau (PI) has done extensive research on ADHD and published 7 SCI papers in ADHD pharmacotherapy. The PI published the first paper in the effectiveness of atomoxetine in improving executive functions among 30 boys with ADHD in the world (International Journal of Neuropsychopharmacology, 2009 Oct 23:1-14. [Epub]). Due to its lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western studies in the past decade; however, there is lack of such information in Asian population except the PI's three SCI papers on adult ADHD. Because little is known about atomoxetine effect in adults with ADHD except symptoms reduction, this proposal aims to investigate the efficacy of atomoxetine beyond symptoms improvement. The significance of this project is its novelty and research and clinical relevance because there is lack of information regarding long-term effect of atomoxetine on neuropsychological and brain imaging functions on adults with ADHD, a high-prevalent mental disorder with long-term impairment in adults.


Condition
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Official Title: The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
atomoxetine group
methylphenidate group
psychological counseling group

Detailed Description:

Specific Aims:

  1. 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.
  2. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will recruit 60 adults, aged 18 to 50, who are diagnosed with ADHD at the PI Gau's Adult ADHD clinic at the Department of Psychiatry, National Taiwan University Hospital.

Criteria

Inclusion Criteria:

  • The inclusion criteria are (1) that subjects had typical ADHD symptoms before 7 years old which meet the DSM-IV-TR ADHD at childhood and currently based on Gau's clinic diagnosis and the ADHD supplement of the K-SADS for adults; (2) that their Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score>4 and psychotropic medication-naïve for the past year; (3) that their IQ greater than 80; and (4) that they consent to this study and they can keep appointments for clinic visits and all tests.

Exclusion Criteria:

These subjects will be excluded from the study if they have any of the following criteria:

  • (1) Comorbid with DSM-IV-TR diagnosis of pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar affective disorder, and mental retardation; (2) In the major depressive episode, comorbid with severe anxiety disorders or during substance intoxication or withdrawal at the time of evaluation; (3) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; (4) A history of alcohol or drug abuse within the past 3 months; (5) The need of psychotropic medications apart from MPH or atomoxetine, including Chinese medicine or health-food supplements that have central nervous system activity; and (6) With visual or hearing impairments, or motor disability which may influence the process of neuropsychological assessment. Subjects will be discontinued from this study in the following circumstances: pregnancy, non-compliance with study drug, an adverse event, subject's request of withdrawal, and loss of follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917371

Contacts
Contact: Susan Shur-Fen Gau, MD, PhD +886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD    +886-2-23123456 ext 66802    gaushufe@ntu.edu.tw   
Principal Investigator: Susan Shur-Fen Gau, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital & College of Medicine
  More Information

No publications provided

Responsible Party: Susan Shur-Fen Gau, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00917371     History of Changes
Other Study ID Numbers: 200903059M
Study First Received: June 8, 2009
Last Updated: November 23, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
adults with attention-deficit hyperactivity disorder
atomoxetine
neuropsychological functioning
brain imaging studies

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014