Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

Lilly

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder; Reading Disorder

Treatments: Drug: placebo; Drug: Atomoxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191906

B4Z-MC-LYCK (Other Identifier)

7955

Details and patient eligibility

About

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

Enrollment: 121 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder

Exclusion criteria

• Patients with Conduct Disorder
• Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
• Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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121 participants in 4 patient groups

Atomoxetine first, then Placebo

Experimental group

Description:

Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks

Treatment:

Drug: Atomoxetine Hydrochloride

Drug: placebo

Placebo first, then Atomoxetine

Experimental group

Description:

Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks

Treatment:

Drug: Atomoxetine Hydrochloride

Drug: placebo

Normal Control

No Intervention group

Description:

Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.

Reading Disordered Control

No Intervention group

Description:

The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.