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Preschool Supplement to Clonidine in ADHD (Kiddie-CAT) (kiddie-CAT)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00414921
First received: December 21, 2006
Last updated: May 20, 2009
Last verified: December 2007
History of Changes

December 21, 2006
May 20, 2009
September 2003
Not Provided
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Teacher rating scale (incorporates both ASQ-Teachers and Iowa Conners’ Teacher rating scale) at 4,8,12, and 16 weeks
Complete list of historical versions of study NCT00414921 on ClinicalTrials.gov Archive Site
the ASQ-Parent (ASQ-P) and Child Global Assessment Scales (C-GAS). Adverse events were monitored using AE logs, the Pittsburgh Side Effects Rating Scale, vital signs and electrocardiograms. [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
ASQ-Parent at 4,8,12, and 16 weeks; Computer Performance Test at baseline, 4,8,12, and 16 weeks ; academic achievement measured by Woodcock-Johnson WJ-R at screening and week 18; classroom observation baseline and week 16
Not Provided
Not Provided
 
Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

The purpose of this study is to evaluate the safety and efficacy of two medications——clonidine and methylphenidate——alone or in combination to treat attention deficit hyperactivity disorder in children ages 4 through 6.

Attention deficit hyperactivity disorder (ADHD) is a disease characterized by one or more symptoms of hyperactivity, impulsivity, or inattention that interfere with school, home, work, or social settings. ADHD does not have clear physical signs that can be seen in an x-ray or a lab test. The disorder only can be identified by looking for certain behaviors, which vary from person to person.

This trial will compare the benefits and side effects of two medications——clonidine and methylphenidate (MPH)——used alone or in combination to treat ADHD in children. MPH is approved by the Food and Drug Administration (FDA) for the treatment of ADHD symptoms in children, and clonidine is FDA-approved for the treatment of hypertension in adults. Stimulant medications such as MPH are known to safely and effectively treat many ADHD symptoms. Such medicines, however, do not cure the condition or improve all ADHD symptoms, and the long-term effectiveness of these medications is not well-known.

In this study, participants will be randomly selected to receive one of four treatments: 1) clonidine; 2) MPH; 3) clonidine and MPH; or 4) a placebo (an inactive substance). Participation in the study is about 16 weeks, and includes a baseline screening and 5 evaluation visits to assess attention, hyperactivity, overall improvement and general functioning, medication side effects, blood pressure, pulse, and weight.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: clonidine
    Clonidine is FDA-approved for the treatment of hypertension in adults
  • Drug: methylphenidate
    Methylphenidate is known to safely and effectively treat many ADHD symptoms.
    Other Name: MPH
  • Other: placebo
    inactive substance
  • Active Comparator: 1
    clonidine
    Intervention: Drug: clonidine
  • Active Comparator: 2
    methylphenidate
    Intervention: Drug: methylphenidate
  • Active Comparator: 3
    methylphenidate and clonidine
    Interventions:
    • Drug: clonidine
    • Drug: methylphenidate
  • Placebo Comparator: 4
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2007
Not Provided

Inclusion Criteria:

  • Child with ADHD
  • Child ages 4 through 6
  • Child attending a structured preschool or daycare

Exclusion Criteria:

  • Presence of a tic disorder of any kind or a known active heart disease for which it would be unsafe to use the study drugs
  • Presence of pervasive developmental disorder, autism, mental retardation, or serious psychiatric illness
  • Child not attending a structured preschool or daycare
Both
4 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414921
R01NS39087_kiddie-CAT
Yes
Floyd R. Sallee, M.D., Ph.D., Professor, University of Cincinnati School of Medicine
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Floyd Randy Sallee, MD/PhD University of Cincinnati
Principal Investigator: Oscar Bukstein, MD Western Psychiatric Institute and Clinic
Principal Investigator: Donna Palumbo, PhD University of Rochester
Principal Investigator: William Pelham, PhD SUNY Buffalo
University of Cincinnati
December 2007

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