An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191737

B4Z-SB-LYDE

7233

Details and patient eligibility

About

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday
• Diagnosis of ADHD
• Normal intelligence

Exclusion criteria

• Weigh less than 30 kg or more than 85 kg at study entry
• Other relevant psychiatric diagnoses
• Are at serious suicidal risk as determined by the investigator
• Have a history of severe allergies
• Alcohol or drug abuse within the past 3 months
• Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)