Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

NCT00485459 | Completed Phase 3

• 2 other identifiers: 8160B4Z-TW-S010
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD

Secondary Outcomes (3)

• Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo

• Compare the reduction in school-related symptoms between atomoxetine and placebo

• Assess the safety and tolerability of once-daily dosing of atomoxetine

Interventions

Atomoxetine Hydrochloride DRUG

Placebo DRUG

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
• Subjects must be aged 6 to 16 years
• Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
• Subjects must be able to swallow capsules
• Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.

You may not qualify if:

• Weigh less than 20 kg or more than 60 kg at study entry
• Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
• Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
• Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
• Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Taipei, Taiwan

Location

Related Publications (1)

• Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.

  PMID: 25019647 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: February 1, 2004
• Study Completion: November 1, 2004
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

TW (1)