ADHD Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD)
Verified date | June 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
Status | Completed |
Enrollment | 215 |
Est. completion date | July 2, 2004 |
Est. primary completion date | July 2, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - Primary diagnosis of ADHD combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation - Capable of understanding and following classroom instructions - Generally functioning academically at age-appropriate levels Exclusion Criteria: - ADHD, predominantly inattentive subtype - Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD, severe depressive or severe anxiety disorder - Documented history of aggressive behavior serious enough to preclude participation in regular classroom activities - Documented allergies or intolerance to either of the active treatments or tricyclic antidepressants |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Shire |
United States,
Wigal SB, McGough JJ, McCracken JT, Biederman J, Spencer TJ, Posner KL, Wigal TL, Kollins SH, Clark TM, Mays DA, Zhang Y, Tulloch SJ. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in s — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) | Approximately 3 weeks | ||
Secondary | PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL | Approximately 3 weeks | ||
Secondary | treatment-emergent adverse events | approximately 3 weeks |
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