Attention-Deficit/Hyperactivity Disorder (AD/HD) MedDRA version: 23.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder. Are the trial subjects under 18? yes Number of subjects for this age range: 121 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients with Conduct Disorder 2) Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder. 3) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to test the hypothesis that acute treatment for approximately 4 weeks with atomoxetine provides superior efficacy compared with placebo in patients with Attention-Deficit/Hyperactivity Disorder-Combined Type (ADHD-C), Reading Disorder (RD) without ADHD, and comorbid ADHD-C and RD (ADHD-C+RD) as measured by improvement in speed of inhibition as shown by a statistically significantly shorter Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm.;Secondary Objective: To measure: a) In the subset of patients aged 10 years and older, compare performance. b) Compare performance in: ADHD-C, RD, and ADHD-C+RD with the normal control and reading disordered control groups on SSRT and a reading task (lexical decision task). c) Establish the specificity of effect of atomoxetine upon SSRT and a phonological and lexical decision task. d) Determine the effect of atomoxetine compared with placebo upon impulsivity. e) Determine the effect of atomoxetine compared with placebo upon working memory f) Test the hypothesis that atomoxetine is superior to placebo in reducing symptoms of ADHD. g) Compare the clinical effect of atomoxetine to placebo in reducing symptoms of ADHD, using the Clinical Global Impression-Attention- Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I). h) Compare the safety and tolerability of atomoxetine with placebo as assessed by adverse events (AEs) elicited during open-ended questioning.;Primary end point(s): Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm;Timepoint(s) of evaluation of this end point: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset b) 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 c) Lexical Decision Task Mean Reaction Time: Correct Words d) Lexical Decision Task Mean Reaction Time: Pseudo Words e) Working Memory by Corsi Block Tapping Test (CBTT) f) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score g) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale h) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale i) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score j) Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale k) Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale l) Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones m) Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words n) 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 o) 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 ;Timepoint(s) of evaluation of this end point: a, b) Baseline and 4 weeks of therapy c,d,e,f,g,h,i) Baseline and Week 4 of initial therapy and Week 4 of crosso | — |
Countries
Belgium, Netherlands
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed