Atomoxetine vs Placebo in the Treatment of ADHD in Swedish Children and Adolescents

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Placebo

Drug: Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

6671

B4Z-SO-LY15

Details and patient eligibility

About

Comparison of the effect of Atomoxetine and psychoeducation with placebo and psychoeducation after 10 weeks of treatment

Sex

All

Ages

7 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the criteria for ADHD of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) as well as severity criteria. Diagnosis is assessed by the investigator's clinical evaluation as well as administration of the K-SADS-PL structured interview.
Meet a symptom severity threshold of 1.5 standard deviations above age and sex norms for their diagnostic subtype on the ADHDRS-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) This severity threshold must be met at Visit 1 and maintained at Visit 2.
Be at least 7 years of age, but not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
For female subjects of child-bearing potential only, test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control.

Exclusion criteria

Weigh less than 20 kg at study entry
Have a documented history of Bipolar Disorder or any history of psychosis or pervasive development disorder (autistic spectrum disorder).
Are pregnant or breastfeeding.
Are at serious suicidal risk as assessed by the investigator.
Have been treated previously for ADHD with pyschostimulants such as Methylphenidate or Ritalin