Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2004-03-24
• Target enrollment: 0
• Participant gender: All

Summary

Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Adderall; Amphetamine

Criteria

Inclusion Criteria:

• Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD

Exclusion Criteria:

• Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD

• Known non-responder to stimulant medication

• Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines

• Conduct Disorder, hypertension, history of seizure

• Tic disorder or Tourette's disorder