Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine Hydrochloride; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191945

8836

B4Z-XM-LYDM (Other Identifier)

Details and patient eligibility

About

Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Enrollment: 151 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
2. Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
3. Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or International Statistical Classification of Diseases and Related Health Problems [World Health Organisation; 10th Revision] [ICD 10] criteria) within 3 months prior to Visit 1.

Exclusion criteria

1. Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis.
2. Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 2 patient groups, including a placebo group

Atomoxetine

Experimental group

Description:

atomoxetine: 0.5 mg/kg/day every day (QD),by mouth (PO) for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year

Treatment:

Drug: Atomoxetine Hydrochloride

Placebo

Placebo Comparator group

Description:

placebo every day (QD), by mouth (PO) for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year (open-label extension)

Treatment:

Drug: placebo

Drug: Atomoxetine Hydrochloride