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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

Tracking Information
First Submitted Date  ICMJE January 29, 2007
First Posted Date  ICMJE January 31, 2007
Results First Submitted Date  ICMJE January 18, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE January 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2007)
Score on ADHD IV Rating Scale (ADHD-RS) (measured at Month 14)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2007)
  • Score on behavioral ratings
  • Tests of academic performance
  • Cognitive test measures
  • Global measures of functioning (all measured at Month 14)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Group 1: Guan-Guan+Placebo
    weeks 1-4: Guanfacine weeks 5-8: Guanfacine + Placebo
    Intervention: Drug: Guanfacine
  • Active Comparator: Group 2: Placebo-Placebo+DMPH
    weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
    Intervention: Drug: Methylphenidate (MPH)
  • Experimental: Group 3: Guan-Guan+DMPH (Comb)
    weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH
    Interventions:
    • Drug: Guanfacine
    • Drug: Methylphenidate (MPH)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2017)
212
Original Enrollment  ICMJE
 (submitted: January 29, 2007)
180
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00429273
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James McCracken, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: James T. McCracken, MD University of California, Los Angeles
Study Director: James J. McGough, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP