Phase 4
N=207
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT00429273 ↗Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) — -7.77; -7.99; -10.66; -4.14 units on a scale — p=<.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Guanfacine (Drug); Methylphenidate (MPH) (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) |
-7.77; -7.99; -10.66; -4.14; -4.10; -5.89 | <.01 sig |
Summary
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00429273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.