Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Recruitment status was Recruiting
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Purpose
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: Guanfacine Drug: Methylphenidate (MPH) Drug: Combined methylphenidate and guanfacine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years |
- Score on ADHD IV Rating Scale (ADHD-RS) [ Time Frame: Measured at baseline and Weeks 0 to 8 ] [ Designated as safety issue: No ]
- Score on behavioral ratings CGI-Improvement, Conners Global Index and cognitive test measures [ Time Frame: Measured at baseline and Weeks 0 to 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
Participants will take guanfacine only
|
Drug: Guanfacine
Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures
Other Name: Tenex
|
|
Active Comparator: Group 2
Participants will take methylphenidate only
|
Drug: Methylphenidate (MPH)
Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.
Other Name: Focalin XR
|
|
Experimental: Group 3
Participants will take guanfacine and methylphenidate combined
|
Drug: Combined methylphenidate and guanfacine
Dosing as described for guanfacine and methylphenidate
|
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 also have difficulty relating with peers. If left untreated, the disorder may cause adverse effects that can last into adolescence and adulthood. Stimulant medications, such as methylphenidate, are effective in reducing ADHD symptoms on a short-term basis. However, few long-term benefits in academic or general functioning from current ADHD therapies have been demonstrated. Focalin XR is a stimulant medication that is FDA-approved for treating ADHD. Guanfacine is another medication that is currently approved for the treatment of hypertension, but has long been used for treating ADHD. This study will determine the effectiveness of a combination of Focalin XR and guanfacine in enhancing cognitive functioning and improving the long-term benefit of ADHD treatment.
Participants in this study will be randomly assigned to one of three treatment regimens: Focalin XR and placebo; guanfacine and placebo; or Focalin XR and guanfacine. The study will be conducted in two phases: an 8-week double-blind treatment phase and a 12-month open-label treatment phase. In Phase I, one third of participants will receive placebo for the initial 4 weeks, followed by Focalin XR alone for the remaining 4 weeks. All other participants will receive their assigned medications for the full 8 weeks. All participants will attend two study visits prior to beginning treatment and one study visit per week throughout Phase I. At the end of Phase I, treatment assignments will be unblinded. Participants who experienced adequate improvement with their assigned treatment will then continue in Phase II on the same medication(s) for an additional 12 months. Participants will attend study visits once per month until the end of the study. Study visits will include self-report measures, clinical assessments, and cognitive testing. Participants will also undergo four electroencephalography (EEG) tests and two fMRI scans over the course of the study. All Phase II participants will receive a follow-up telephone call 1 month after the final study visit.
Eligibility| Ages Eligible for Study: | 7 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00429273
| Contact: Joni Zuckerbrow-Miller | 310-295-7667 | jzuckerbrow@mednet.ucla.edu |
| United States, California | |
| University of California Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Fiona Whelan, M.S. 310-825-7874 fwhelan@mednet.ucla.edu | |
| Principal Investigator: James T. McCracken, MD | |
| Sub-Investigator: James J. McGough, MD | |
| Sub-Investigator: Robert Bilder, Ph.D. | |
| Principal Investigator: | James T. McCracken, MD | University of California, Los Angeles | |
| Study Director: | James J. McGough, MD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | James McCracken, MD, UCLA |
| ClinicalTrials.gov Identifier: | NCT00429273 History of Changes |
| Other Study ID Numbers: | P50 MH077248-01, DDTR B2-NDH |
| Study First Received: | January 29, 2007 |
| Last Updated: | October 5, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
ADHD Guanfacine Methylphenidate Focalin XR |
Pediatric Cognitive function Combination therapy |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Dyskinesias Mental Disorders Mental Disorders Diagnosed in Childhood Nervous System Diseases Neurologic Manifestations Signs and Symptoms Guanfacine Methylphenidate Adrenergic Agents Adrenergic Agonists Adrenergic alpha-2 Receptor Agonists |
Adrenergic alpha-Agonists Antihypertensive Agents Cardiovascular Agents Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015