Phase 4
Completed N=112
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
Source: ClinicalTrials.gov NCT00760747 ↗Enrolled (actual)
112
Serious AEs
1.8%
Results posted
Sep 2011
Primary outcomePrimary: 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 — -14.3; -15.0 units on a scale — p=0.692
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-14.3; -15.0 | 0.692 |
| PRIMARY Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint |
-8.0; -8.1 | 0.927 |
| SECONDARY Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint |
-0.6; -0.4 | 0.456 |
| SECONDARY Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint |
-1.0; -0.8 | 0.517 |
| SECONDARY Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint |
-1.3; -1.2 | 0.526 |
| SECONDARY Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint |
-1.7; -1.7 | 0.898 |
| SECONDARY Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint |
3.4; 2.2; 0.7; 4.1; 4.9; 2.9 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint |
-0.7; -0.5 | — |
| SECONDARY Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint |
1.5; 1.9; 1.2; 0.5; 2.3; 3.1 | — |
| SECONDARY Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint |
6.8; 4.2; 3.4; 5.9 | — |
| SECONDARY Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint |
-0.4; 0.6; 0.6; 1.1 | — |
| SECONDARY Number of Participants With Suicidal Behaviors and Ideations |
1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00760747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.