Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190736
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007

September 12, 2005
November 5, 2007
September 2004
Not Provided
Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults.
Not Provided
Complete list of historical versions of study NCT00190736 on ClinicalTrials.gov Archive Site
Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults.
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Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition

A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
ADHD
  • Drug: Atomoxetine Hydrochloride
  • Drug: placebo
Not Provided
Adler LA, Spencer T, Brown TE, Holdnack J, Saylor K, Schuh K, Trzepacz PT, Williams DW, Kelsey D. Once-daily atomoxetine for adult attention-deficit/hyperactivity disorder: a 6-month, double-blind trial. J Clin Psychopharmacol. 2009 Feb;29(1):44-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
September 2006
Not Provided

Inclusion Criteria:

  • Male and Female patients with ADHD ages 18-54.
  • Patient must have ADHD symptoms that cause problem(s) in the home setting.

Exclusion Criteria:

  • Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication.
  • Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1
Both
18 Years to 54 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00190736
9040, B4Z-US-LYCU
Not Provided
Not Provided
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
November 2007

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