The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults ADHD

NCT00917371 | Completed DMC

• 1 other identifier: 200903059M
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

adults with attention-deficit hyperactivity disorder; atomoxetine; neuropsychological functioning; brain imaging studies

Study Arms (3)

atomoxetine group

methylphenidate group

psychological counseling group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Lin HY, Gau SS. Atomoxetine Treatment Strengthens an Anti-Correlated Relationship between Functional Brain Networks in Medication-Naive Adults with Attention-Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Int J Neuropsychopharmacol. 2015 Sep 16;19(3):pyv094. doi: 10.1093/ijnp/pyv094.

  PMID: 26377368 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Susan Shur-Fen Gau, MD, PhD

  National Taiwan University Hospital & College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: August 1, 2010
• Primary Completion: July 31, 2011
• Study Completion: July 31, 2011
• Last Updated: September 5, 2021

Record last verified: 2010-11

Locations

TW (1)