Evaluation of Continuous Symptom Treatment of ADHD

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00486122
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 11, 2007
June 11, 2007
September 2003
Not Provided
Test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD
Same as current
No Changes Posted
  • Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy compared with placebo in children with ADHD
  • Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the evenings compared with placebo in children with ADHD
  • Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD based on the CGIP-M
  • To assess the effect of dosing atomoxetine in the morning versus placebo on measures of executive functioning
  • Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy compared with placebo for measures of adaptive functioning in children with ADHD
  • Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy in the evenings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
  • Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
  • To examine the onset of action during the first week of treatment in the morning versus in the evening versus placebo
  • To assess the effect of dosing atomoxetine in the evening versus placebo on measures of executive functioning
  • To compare morning versus evening dosing versus placebo as assessed by the CGI-ADHD-S
  • To assess the safety and tolerability of atomoxetine dosed in the morning versus in the evening versus placebo
Same as current
Not Provided
Not Provided
 
Evaluation of Continuous Symptom Treatment of ADHD
Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera

The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Atomoxetine Hydrochloride
  • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
282
June 2004
Not Provided

Inclusion Criteria:

  • Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised
  • Males or females who are at least 6 years old and no more than 12 years old prior to visit 2
  • Patients must be able to swallow capsules
  • Patients 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 70 or more if formal IQ testing were administered.
  • Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)

Exclusion Criteria:

  • Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1)
  • Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis
  • Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder.
  • Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient
  • Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00486122
7972, B4Z-US-LYCC
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
June 2007

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