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.
Overview
- Phase
- Phase 4
- Intervention
- Atomoxetine Hydrochloride
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Eli Lilly and Company
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Atomoxetine first, then Placebo
Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks
Intervention: Atomoxetine Hydrochloride
Atomoxetine first, then Placebo
Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks
Intervention: placebo
Placebo first, then Atomoxetine
Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks
Intervention: Atomoxetine Hydrochloride
Placebo first, then Atomoxetine
Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks
Intervention: placebo
Outcomes
Primary Outcomes
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm
Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy
SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.
Secondary Outcomes
- Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset(Baseline and 4 weeks of therapy)
- Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset(Baseline and 4 weeks of therapy)
- Lexical Decision Task Mean Reaction Time: Correct Words(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Lexical Decision Task Mean Reaction Time: Pseudo Words(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Working Memory by Corsi Block Tapping Test (CBTT)(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score(Baseline and Week 4 of initial therapy and Week 4 of crossover therapy)
- Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale(4 week therapy endpoint)
- Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale(4 week therapy endpoint)
- Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones(Baseline and 4 weeks of therapy)
- Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words(Baseline and 4 weeks of therapy)
- Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones(Baseline and 4 weeks of therapy)
- Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words(Baseline and 4 weeks of therapy)