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OpenTrials
Completed

NCT Number: NCT00191035

Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, Pasadena, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have ADHD.
  • Must be 13-16 years of age.
  • Must be able to swallow capsules.
  • Expected to achieve score of 70 or more on IQ test
  • Willing and reliable to keep appts. for clinic visits and test

Exclusion criteria

  • Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
  • Patients who weigh less than 40 kg or greater than 70 kg.
  • Patients with documented history of Bipolar I or II disorder, or psychosis
  • Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder

Treatment and study plan

Atomoxetine

Drug

Primary outcomes

  1. Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv

Secondary outcomes

  1. Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD

Important dates

Study start
2004
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Dec 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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