A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study treatment period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride; Methylphenidate

Criteria

Inclusion Criteria:

• Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD), confirmed at screening by administering the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version.

• Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale - IV - Parent Version: Investigator Administered and Scored, total score of less than or equal to 20 at screening and baseline.

• Patients must have a Clinical Global Impression-Attention-Deficit/Hyperactivity Disorder-Improvement score of 1 ("very much better") or 2 ("much better") at screening and baseline.

• Patients must have been taking either atomoxetine or osmotic-release oral system methylphenidate for the treatment of ADHD between 3 and a maximum of 15 months prior to screening.

• Patients must have been receiving the same dose of atomoxetine or osmotic-release oral system methylphenidate as monotherapy in a single daily dose during the 4 weeks prior to screening.

• For females of child-bearing potential only: Test negative for pregnancy at the time of entry based on a urine pregnancy test

• Signed informed consent document (ICD)

Exclusion Criteria:

• Patients who weigh less than 20 kilograms (kg) or more than 70 kg at study entry

• Documented history of bipolar disorder, any history of psychosis or pervasive development disorder.

• Patients with a history of any seizure disorder or patients who have taken anticonvulsant treatment for seizure control.

• Patients at serious suicidal risk.

• History of severe allergies to more than one class of medications or have had multiple adverse drug reactions.

• Patients with acute or unstable medical conditions including cardiovascular disease and hypertension.

• Patients taking excluded concomitant medications or likely to begin structured psychotherapy for ADHD.

• Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial.

• Sexually active females who do not use a medically acceptable method of contraception.