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

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ClinicalTrials.gov Identifier: NCT00507065
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
ADHD Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Amphetamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Adderall XR (10 mg) Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
Experimental: Adderall XR (20 mg) Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
Experimental: Adderall XR (30 mg) Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
Experimental: Adderall XR (40 mg) Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
Placebo Comparator: placebo Drug: Placebo



Primary Outcome Measures :
  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. [ Time Frame: approximately 4 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Approximately 4 weeks ]
  2. Adverse events, labs, physical exam, ECG [ Time Frame: approximately 4 weeks ]


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507065


Locations
United States, New York
New York University - Child Study Center
New York, New York, United States
Sponsors and Collaborators
Shire
Investigators
Study Director: Raymond Pratt, MD Shire

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00507065     History of Changes
Other Study ID Numbers: SLI381-314A
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: November 2007

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Amphetamine
Adderall
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors