A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning Compared With Fast Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint
Study Overview
Brief Summary
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.
Detailed Description
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Outpatients between 6-16 years of age
- •Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD must be met
- •Normal laboratory and electrocardiogram (ECG) results
- •Normal intelligence
- •Must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy
Exclusion Criteria
- •Less than 20 kg or more than 70 kg at study entry
- •Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk
- •Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions
- •Taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor
- •Immediate need for stimulant discontinuation due to tolerability problems
- •Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine
Arms & Interventions
Slow Switching Group
Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2 mg/kg/day, orally (PO), during 10 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks
Intervention: Atomoxetine (Drug)
Fast Switching Group
Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2 mg/kg/day, PO, during 2 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks
Intervention: Atomoxetine (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint
Time Frame: Baseline, 10 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
Time Frame: Baseline, 2 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Secondary Outcomes
- Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint(Baseline, 10 weeks)
- Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint(Baseline, 10 weeks)
- Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint(Baseline, 10 weeks)
- Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint(Baseline, 10 weeks)
- Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint(Baseline, 10 weeks)
- Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint(Baseline, 10 weeks)
- Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint(Baseline, 6 weeks, 14 weeks)
- Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint(Baseline, 6 weeks, 14 weeks)
- Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint(Baseline, 6 weeks, 14 weeks)
- Number of Participants With Suicidal Behaviors and Ideations(Baseline through 14 weeks)