Status:
COMPLETED
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
7-14 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school. They...
Eligibility Criteria
Inclusion
- Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview
- Clinical Global Impression-Severity score of at least 4 for ADHD
- Resided with primary caretaker for at least 6 months prior to study entry
Exclusion
- History of autism, pervasive developmental disorder, chronic tic disorder, psychosis, or bipolar disorder
- Current major depression or panic disorder
- Systolic or diastolic blood pressure at screening greater than the 95th percentile or less than the 5th percentile for age and body mass index (BMI)
- Any medical condition that might make stimulant or alpha agonist therapy medically inadvisable
- Need for chronic use of other medications with central nervous system effects
- Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test
- History of structural heart defects, syncope, or fainting while exercising
- Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at study entry
- Mental retardation as determined by clinical functional assessment and an IQ estimate of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00429273
Start Date
January 1 2007
End Date
July 1 2011
Last Update
July 30 2021
Active Locations (1)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095