Attention-Deficit/Hyperactivity Disorder 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) ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder - Not Otherwise Specified [PDD NOS]) 2) Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD) 3) At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version 4) Intelligence quotient (IQ) score > 60 Are the trial subjects under 18? yes Number of subjects for this age range: 97 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) weight under 20 kg 3) patients at serious suicidal risk. 4) Contraindication to the use of atomoxetine 5) Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that atomoxetine given at a dose up to 1.2 mg/kg/day (once daily) for 8 weeks is superior to placebo in the treatment of symptoms of Attention-Deficit/Hyperactivity Disorder (ADI-ID) in in-and outpatients aged 6 through 17 years with a diagnosis of Autism Spectrum Disorder (ASD). ;Secondary Objective: 1) To assess the efficacy of acute treatment with up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks on symptoms of ADI-ID. 2) To assess the efficacy of maintenance treatment with atomoxetine during open label follow-up on symptoms of ADHD. 3) To assess the safety and tolerability of up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks and of atomoxetine dilling open label follow up in pediatric patients with ASD and ADI-ID symptoms. 4) To assess the effect of up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks and of atomoxetine during open label follow up on sleeping patterns as measured by the Sleep Measures scale. 5) To assess the effect of up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks and of atomoxetine during open label follow up on ASD symptoms as measured by the Aberrant Behavior Checklist (ABC) and the Children's Social Behavior Questionnaire (CSBQ).;Primary end point(s): ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score;Timepoint(s) of evaluation of this end point: Baseline, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I) at 28 weeks. b) Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S) at 28 weeks. c) ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score at 28 weeks. d) Sleep Measure Scale at 28 weeks. c) Aberrant Behavior Checklist (ABC) at 28 weeks. d) Children's Social Behavior Questionnaire (CSBQ) Total Score at 28 weeks. e) General Health Questionnaire (GHQ) Total Score at 28 weeks f) Nijmeegse Ouderlijke Stress Index (NOSI) Total Score at 28 weeks g) Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates at 28 weeks h) Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections at 28 weeks i) Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections at 8 weeks j) Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates at 8 weeks k) Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections at 8 weeks l) Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections at 8 weeks m) Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy at 8 weeks n) Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement at 8 weeks o) Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates at 8 weeks. p) Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates at 8 weeks q) Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times at 8 weeks r) Cytochrome P450 2D6 Genotype (Baseline) ;Timepoint(s) of evaluation of this end point: a-j) Baseline, 16 weeks k-t) Baseline, 32 weeks | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed