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

ADHD Clinical Trial

Official title:

A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507065
• Other study ID #: SLI381-314A
• Status: Completed
• Phase: Phase 3
• Start date: May 28, 2003
• Est. completion date: March 24, 2004

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: March 24, 2004
• Est. primary completion date: March 24, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Mixed salts of a single-entity amphetamine (ADDERALL XR)

• Placebo

Locations

Country	Name	City	State
United States	New York University - Child Study Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, dou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse events, labs, physical exam, ECG		approximately 4 weeks

External Links

•   FDA Recall information