Long-Term, Open Label Atomoxetine Study on Attention Deficit Hyperactivity Disorder

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with ADHD who take the drug for about 5 years (long-term).

Official Title

Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder

Conditions

Attention Deficit Hyperactivity Disorder

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• To assess long-term safety and tolerability of atomoxetine in patients who participated in a previous atomoxetine study with a diagnosis of ADHD.

Secondary Outcome Measures:

• To assess long-term efficacy of patients treated with atomoxetine, as measured by the change in total score from the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv).
• To assess long-term efficacy of patients treated with atomoxetine, as measured by the Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S).
• To assess long-term efficacy of patients treated with atomoxetine, as measured by the Conners’ Parent Rating Scale-Revised: Short Form (CPRS-R:S).

Study Start

August 2000; Study completion: September 2008

Eligibility & Criteria

• Ages Eligible for Study: 6 Years – 18 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study.
• Must meet the study criteria for ADHD
• Must be willing to have blood drawn and to complete other test required for this study

Exclusion Criteria:

• allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
• taking certain medicines that could interact with atomoxetine
• plan to move too far away from a doctor participating in this study in the next 5 years
• current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study.

Total Enrolment

1500

Contact Details

• Wallsend, New South Wales, 2287, Australia
• South Brisbane, Queensland, 4101, Australia
• West Perth, Western Australia, 6005, Australia

See Lilly Clinical Trials for more information.Published Results of this study