NCT00529893

Brief Summary

The purpose of this study is examine the efficacy of atomoxetine on executive functioning measures including the Continuous Performance Test (CPT) and the executive function measures of the Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 7, 2021

Status Verified

October 1, 2013

Enrollment Period

11 months

First QC Date

September 13, 2007

Last Update Submit

May 6, 2021

Conditions

Keywords

Attention-deficit/Hyperactivity Disorderneuropsychological functioningAtomoxetine

Outcome Measures

Primary Outcomes (1)

  • The Efficacy of Once-Daily Atomoxetine Hydrochloride on Executive Function in Taiwanese Children with Attention-deficit/ Hyperactivity Disorder

    Patients with ADHD performed worse in the backward digit span task, CPT, IED and RVIP than the controls. Their significant improvement in executive function after treatment with atomoxetine for 4 weeks included fewer omission and commission errors, fewer hit reaction time standard errors, and less variability in the CPT; fewer total errors and trials in the IED; higher probability of hits, total correction rejection, and total hits, fewer total misses, and shorter latency in the RVIP; longer span length and fewer total usage errors in the SSP; fewer errors and strategy utilization in the SWM; and more problems solved, fewer mean moves, and shorter subsequent thinking time in the SOC. Atomoxetine significantly reduced ADHD-related symptoms over time.

    12 weeks

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Subjects are diagnosed as DSM-IV, Attention Deficit Hyperactivity Disorder (ADHD).

You may qualify if:

  • (1) subjects had the clinical diagnosis and the K-SADS-E of DSM-IV ADHD; (2) their ages range from 10 to 15; (3) subjects must not have taken any medication used to treat ADHD; (4) subjects' IQ should be larger than 80; (5) subjects and their parents and teachers consent to participate and have the ability to complete self-administered measures in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Gau SS, Shang CY. Improvement of executive functions in boys with attention deficit hyperactivity disorder: an open-label follow-up study with once-daily atomoxetine. Int J Neuropsychopharmacol. 2010 Mar;13(2):243-56. doi: 10.1017/S1461145709990836. Epub 2009 Oct 23.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    Dept of Psychiatry, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 7, 2021

Record last verified: 2013-10

Locations