Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191035
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 13, 2006
Information provided by:
Eli Lilly and Company

September 12, 2005
September 19, 2005
December 13, 2006
March 2004
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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
Same as current
Complete list of historical versions of study NCT00191035 on Archive Site
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
Same as current
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Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD
Maintenance of Benefit After 8-Week and 52-Week Treatment 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
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
Drug: Atomoxetine
Not Provided
Wietecha LA, Williams DW, Herbert M, Melmed RD, Greenbaum M, Schuh K. Atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):719-30. doi: 10.1089/cap.2008.074.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2006
Not Provided

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
Sexes Eligible for Study: All
13 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP