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

Completed · Phase 3 · Has a placebo group

Conditions studied: ADHD

In brief

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).

Key facts

Study ID

NCT00507065

Run by

Shire

People needed

329

Starts

2003-05-28

Expected to finish

2004-03-24

Last updated by the study team

2021-06-08

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• New York University - Child Study Center — New York, New York, United States

Full record on ClinicalTrials.gov

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