ADHD
Conditions
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).
Interventions
DRUGMixed salts of a single-entity amphetamine (ADDERALL XR)
DRUGPlacebo
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed