A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents (ADHD LIFE)

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine; Drug: Other standard therapy for ADHD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447278

B4Z-EW-LYDY (Other Identifier)

11576

Details and patient eligibility

About

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

Enrollment: 399 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria:

  • 6 to 16 years old
  • Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
  • Pharmacological naïve
  • Normal intelligence as assessed by investigator
  • Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion criteria

• Exclusion criteria

  • History of bipolar disorder, any history of psychosis or autism spectrum disorder
  • History of any seizure disorder
  • Significant prior or current medical conditions
  • History of alcohol or drug abuse within the past 3 months
  • Patients who are taking concurrently any of the excluded medications in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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399 participants in 2 patient groups

Atomoxetine

Experimental group

Description:

0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

Treatment:

Drug: Atomoxetine

OEST

Active Comparator group

Description:

Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Treatment:

Drug: Other standard therapy for ADHD