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

Phase 3

Completed

• Conditions: ADHD
• Interventions: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR); Drug: Placebo

• Registration Number: NCT00507065
• Lead Sponsor: Shire

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05-28
• Primary Completion: 2004-03-24
• Study Completion: 2004-03-24
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adderall XR (30 mg)	Mixed salts of a single-entity amphetamine (ADDERALL XR)	-
Adderall XR (40 mg)	Mixed salts of a single-entity amphetamine (ADDERALL XR)	-
placebo	Placebo	-
Adderall XR (10 mg)	Mixed salts of a single-entity amphetamine (ADDERALL XR)	-
Adderall XR (20 mg)	Mixed salts of a single-entity amphetamine (ADDERALL XR)	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.	approximately 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts.	Approximately 4 weeks
Adverse events, labs, physical exam, ECG	approximately 4 weeks

Trial Locations

Locations (1)

New York University - Child Study Center; 🇺🇸 New York, New York, United States