Phase 3
Completed N=151
Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00191945 ↗Enrolled (actual)
151
Serious AEs
0.7%
Results posted
Jan 2010
Primary outcomePrimary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint — 26.3; 34.8 units on a scale — p=<0.001
Summary
Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint |
26.3; 34.8 | <0.001 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks |
27.3; 34.4 | <0.001 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks |
28.7; 34.4 | 0.0009 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks |
31.2; 35.5 | 0.0033 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 |
28.7; 34.4; 26.3; 34.8 | 0.013 sig |
| SECONDARY Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) |
5.06; 5.04; 3.89; 4.5 | — |
| SECONDARY Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) |
5.1; 3.2 | — |
| SECONDARY Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) |
54.6; 54.7; 37.8; 48.5 | <0.001 sig |
| SECONDARY Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) |
38.0; 39.0; 42.8; 44.4; 42.1; 41.8 | 0.810 |
| SECONDARY Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) |
46; 22; 28; 10; 16; 9 | — |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension) |
21.4 | — |
| SECONDARY Vital Signs - Systolic Blood Pressure |
98.7; 102.2; 102.9; 101.2 | — |
| SECONDARY Vital Signs - Diastolic Blood Pressure |
56.4; 58.2; 59.3; 57.5 | — |
| SECONDARY Vital Signs - Pulse |
75.8; 77.0; 84.5; 79.0 | — |
| SECONDARY Vital Signs - Weight |
38.0; 37.5; 37.0; 38.9 | — |
Eligibility Criteria
Inclusion Criteria
- Child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
- Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
- Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or International Statistical Classification of Diseases and Related Health Problems [World Health Organisation; 10th Revision] [ICD 10] criteria) within 3 months prior to Visit 1.
Exclusion Criteria
- Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis.
- Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
Data sourced from ClinicalTrials.gov (NCT00191945). 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.