| September 12, 2005 |
| September 19, 2008 |
| April 2005 |
| December 2007 (final data collection date for primary outcome measure) |
| Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] |
| After 4 weeks of therapy, improvement in speed of inhibition as shown by a statistically significant shorter Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm. |
| Complete list of historical versions of study NCT00191906 on ClinicalTrials.gov Archive Site |
- In subset of patients 10 years or older, compare performance on SSRT and a phonological task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Compare performance between groups on SSRT and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Working memory by Corsi Block Tapping Test (CBTT) [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
- Adverse Events (AEs) [ Time Frame: over 6 weeks ] [ Designated as safety issue: Yes ]
|
- After 4 weeks of therapy, in subset of patients 10 years or older, compare performance on SSRT and a phonological task.
- After 4 weeks of therapy, compare performance between groups on SSRT and lexical decision task.
- After 4 weeks of therapy, compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task.
- After 4 weeks of therapy, compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls.
|
| |
| Comparison of Atomoxetine and Placebo in Children With ADHD and/or Reading Disorder |
| A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder. |
To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type ADHD, patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
- Attention Deficit Hyperactivity Disorder
- Reading Disorder
|
- Drug: Atomoxetine Hydrochloride
- Drug: placebo
|
- Experimental: Atomoxetine, 1.2 mg/kg/day, PO for 4 weeks, 2 week washout period and cross-over to placebo, QD, PO for 4 weeks
- Experimental: Placebo, QD, PO for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks
|
| |
| |
| Completed |
| 76 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder
Exclusion Criteria:
- Patients with Conduct Disorder
- Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
- Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.
|
| Both |
| 8 Years to 12 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Netherlands |
| |
| NCT00191906 |
| Chief Medical Officer, Eli Lilly |
| 7955, B4Z-MC-LYCK |
| Eli Lilly and Company |
|
| Study Director: |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 . Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST) |
Eli Lilly and Company |
|
|
| Eli Lilly and Company |
| September 2008 |