Phase 4
Completed N=207
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00429273 ↗
Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) — -7.77; -7.99; -10.66; -4.14 units on a scale — p=<.01
◆ Published Evidence
Established
79citations · ~26 / year
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Summary
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
Linked Publications (5)
-
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD).
-
Acute and Long-Term Cardiovascular Effects of Stimulant, Guanfacine, and Combination Therapy for Attention-Deficit/Hyperactivity Disorder.
-
Electrophysiological and Clinical Predictors of Methylphenidate, Guanfacine, and Combined Treatment Outcomes in Children With Attention-Deficit/Hyperactivity Disorder.
-
Methylphenidate, Guanfacine, and Combined Treatment Effects on Electroencephalography Correlates of Spatial Working Memory in Attention-Deficit/Hyperactivity Disorder.
-
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD).
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 |
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) and the linked publication. 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. Informational only — not medical advice.