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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00414921
First received: December 21, 2006
Last updated: May 20, 2009
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: clonidine
Drug: methylphenidate
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2003
Study Completion Date: June 2007
Arms Assigned Interventions
Active Comparator: 1
clonidine
Drug: clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults
Active Comparator: 2
methylphenidate
Drug: methylphenidate
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
Other Name: MPH
Active Comparator: 3
methylphenidate and clonidine
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
Placebo Comparator: 4 Other: placebo
inactive substance

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414921

Locations
United States, New York
University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C
Rochester, New York, United States, 14618
United States, Ohio
University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559
Cincinnati, Ohio, United States, 45267-0559
United States, Pennsylvania
Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Cincinnati
Investigators
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
  More Information

No publications provided

Responsible Party: Floyd R. Sallee, M.D., Ph.D., Professor, University of Cincinnati School of Medicine
ClinicalTrials.gov Identifier: NCT00414921     History of Changes
Other Study ID Numbers: R01NS39087_kiddie-CAT
Study First Received: December 21, 2006
Last Updated: May 20, 2009
Health Authority: United States: Federal Government
United States: University of Cincinnati IRB

Keywords provided by University of Cincinnati:
Attention deficit hyperactivity disorder
ADHD
clonidine
methylphenidate
MPH

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clonidine
Methylphenidate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014