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Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder (Project1)

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ClinicalTrials.gov Identifier: NCT00429273
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James McCracken, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Guanfacine Drug: Methylphenidate (MPH) Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429273


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: James T. McCracken, MD University of California, Los Angeles
Study Director: James J. McGough, MD University of California, Los Angeles
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: James McCracken, Chair, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00429273    
Other Study ID Numbers: P50MH077248-01 ( U.S. NIH Grant/Contract )
P50MH077248-01 ( U.S. NIH Grant/Contract )
DDTR B2-NDH
10-000453 ( Other Identifier: Office for Protection of Human Subjects )
First Posted: January 31, 2007    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 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:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Guanfacine
Methylphenidate
Dexmethylphenidate Hydrochloride
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