Status:
COMPLETED
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Novartis
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
9-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications use...
Detailed Description
ADHD is often treated with stimulant medications, which have demonstrated short-term efficacy in numerous trials. However, treatment is often discontinued prematurely. Although ADHD often persists thr...
Eligibility Criteria
Inclusion
- Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997). Comorbidity will likewise be allowed, to ensure representation.
- Signed informed consent and assent
- Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or equal to 4
- Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be normal for age
- Pulse and blood pressure are within 95% of age and gender mean
- Able to complete study instruments and swallow capsules
- Willing to commit to the entire visit schedule for the study, including at least one visit to UIC Medical Center.
Exclusion
- Previous diagnosis of mental retardation
- Non-responder to either medication at the doses offered in the study in an adequate trial
- Must not have experienced disabling adverse effects with either medication
- Concomitant psychotropic medications are required or medications which might have a CNS effect
- Any other medical condition which represents a contraindication for either treatment is present
- History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance
- Females of childbearing age who are sexually active, do not use acceptable birth control (double protection method), and after counseling, are unwilling to do so
- History of allergic reactions to multiple medications
- A history of psychosis
- Diagnosis of bipolar disorder
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00393042
Start Date
January 1 2006
End Date
February 1 2009
Last Update
April 19 2017
Active Locations (2)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
2
Northbrook HALP Clinic/ADHD Research Center
Northbrook, Illinois, United States, 60062