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

NCT ID: NCT00917371

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

atomoxetine group

No interventions assigned to this group

methylphenidate group

No interventions assigned to this group

psychological counseling group

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Shur-Fen Gau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital & College of Medicine

Locations

National Taiwan Univeristy Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 26377368 (View on PubMed)

Other Identifiers

200903059M

Identifier Type: -

Identifier Source: org_study_id