Phase 3
Completed N=399
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
Source: ClinicalTrials.gov NCT00447278 ↗Enrolled (actual)
399
Serious AEs
1.0%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain — 28.0; 28.3; 8.4; 12.4 T-Scores of units on a scale — p=<0.001
Summary
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain |
28.0; 28.3; 8.4; 12.4; 7.3; 11.7 | <0.001 sig |
| SECONDARY Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain |
7.8; 10.7; 37.7; 41.2; 1.2; -0.9 | 0.002 sig |
| SECONDARY Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance) |
43.4; 43.0; 1.9; 5.2; 2.3; 4.7 | 0.002 sig |
| SECONDARY Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) |
1.02; 0.96; -0.30; -0.35; -0.30; -0.36 | 0.015 sig |
| SECONDARY Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv) |
40.87; 40.35; -18.1; -20.1; -17.6; -20.3 | 0.034 sig |
| SECONDARY Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S) |
5.54; 5.45; -1.88; -1.94; -1.94; -2.06 | 0.366 |
| SECONDARY Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years) |
35.8; 36.5; 4.6; 7.0; 5.1; 8.8 | 0.054 |
| SECONDARY Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years) |
49.1; 49.3; 4.9; 1.5; 3.1; 2.3 | 0.263 |
| SECONDARY Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores |
0.288; 0.329; 0.167; 0.306; 0.373; 0.286 | — |
Eligibility Criteria
Inclusion Criteria
- Inclusion criteria:
- 6 to 16 years old
- Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
- Pharmacological naïve
- Normal intelligence as assessed by investigator
- Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.
Exclusion Criteria
- Exclusion criteria
- History of bipolar disorder, any history of psychosis or autism spectrum disorder
- History of any seizure disorder
- Significant prior or current medical conditions
- History of alcohol or drug abuse within the past 3 months
- Patients who are taking concurrently any of the excluded medications in the study.
Data sourced from ClinicalTrials.gov (NCT00447278). 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.