Phase 3
N=139
An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).
Attention Deficit Hyperactivity Disorder · Oppositional Defiant Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00192023 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale — 42.7; 41.5; -8.1; -2.0 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- atomoxetine 0.5 mg/kg/day (Drug); placebo (Drug); atomoxetine 1.2 mg/kg/day (Drug); atomoxetine 1.2-1.4 mg/kg/day (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale |
42.7; 41.5; -8.1; -2.0 | <0.001 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity |
5.1; 5.1; -0.6; 0.0 | <0.001 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale |
17.2; 17.5; -2.7; -0.3 | 0.001 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score |
20.3; 18.8; -2.1; -1.7 | 0.836 |
| SECONDARY Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised |
28.0; 26.9; -0.5; -0.1 | 0.870 |
| SECONDARY Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores |
11.7; 12.2; -1.2; 0.8; 14.3; 14.2 | 0.002 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form |
27.1; 26.9; 3.6; 1.2 | 0.071 |
| SECONDARY Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores |
7.6; 10.8; -1.1; 0.1; 8.2; 8.5 | 0.002 sig |
Summary
The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.
Eligibility Criteria
Inclusion Criteria
- Child or adolescent patients, male or female outpatients, who are 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 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and ODD and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder (SNAP-IV ADHD) Subscale score at both Visit 1 and 2.
- They must also have a SNAP-IV ODD subscale score of at least 15 at both Visit 1 and Visit 2.
- Other comorbid conditions, are allowed but the diagnosis of ADHD and ODD must be the patient's primary diagnosis.
- Patients must be of normal intelligence in the judgment of the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an Intelligence Quotient (IQ) test). The administration of a formal IQ test is not an entry requirement for the study. Specific learning disabilities are not considered general impairment of intelligence.
Exclusion Criteria
- Patients who weigh less than 20 kilograms (kg) at study entry (Visit 1).
- Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder.
- Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate.
- Patients at serious suicidal risk as assessed by the investigator.
- Patients who, in the investigator's judgment, are likely to need psychotropic medications apart from the drug under the study, including health-food supplements that the investigator feels have central nervous system activity (for example, St. John's Wort, melatonin).
Data sourced from ClinicalTrials.gov (NCT00192023). 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.