Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
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
1 other identifier
interventional
329
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2003
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2004
CompletedFirst Submitted
Initial submission to the registry
July 19, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedJune 8, 2021
June 1, 2021
10 months
July 19, 2007
June 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (5)
Adderall XR (10 mg)
EXPERIMENTALAdderall XR (20 mg)
EXPERIMENTALAdderall XR (30 mg)
EXPERIMENTALAdderall XR (40 mg)
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
New York University - Child Study Center
New York, New York, United States
Related 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, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Feb;28(2):266-79. doi: 10.1016/j.clinthera.2006.02.011.
PMID: 16678648RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2007
First Posted
July 25, 2007
Study Start
May 28, 2003
Primary Completion
March 24, 2004
Study Completion
March 24, 2004
Last Updated
June 8, 2021
Record last verified: 2021-06