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Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder (Project1)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity | Drug: Guanfacine Drug: Methylphenidate (MPH) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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 |
- ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) [ Time Frame: Measured at baseline Week 4 and Week 8 ]
The primary clinical efficacy variable for treatment was the ADHD-RS-IV Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ).
The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3).
Scores are obtained by summing each item; The higher the score, the worse the outcome.
Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27
| Enrollment: | 212 |
| Study Start Date: | January 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1: Guan-Guan+Placebo
weeks 1-4: Guanfacine weeks 5-8: Guanfacine + Placebo
|
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: Placebo-Placebo+DMPH
weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
|
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: Guan-Guan+DMPH (Comb)
weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH
|
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
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
|
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: Methylphenidate (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 (Child) |
| Sexes Eligible for Study: | All |
| 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
| United States, California | |
| University of California Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | James T. McCracken, MD | University of California, Los Angeles |
| Study Director: | James J. McGough, MD | University of California, Los Angeles |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | James McCracken, Chair, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00429273 History of Changes |
| Other Study ID Numbers: |
P50MH077248-01 ( U.S. NIH Grant/Contract ) DDTR B2-NDH 10-000453 ( Other Identifier: Office for Protection of Human Subjects ) |
| Study First Received: | January 29, 2007 |
| Results First Received: | January 18, 2017 |
| Last Updated: | May 12, 2017 |
Keywords provided by James McCracken, University of California, Los Angeles:
|
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 Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate Dexmethylphenidate Hydrochloride Guanfacine Central Nervous System Stimulants |
Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on September 19, 2017