Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Attention Deficit Hyperactivity Disorder Clinical Trial

— kiddie-CAT  

Official title:

Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414921
• Other study ID #: R01NS39087_kiddie-CAT
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2006
• Last updated: May 20, 2009
• Start date: September 2003
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: University of Cincinnati IRB
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults
• methylphenidate
Methylphenidate is known to safely and effectively treat many ADHD symptoms.

Other:
• placebo
inactive substance

Locations

Country	Name	City	State
United States	University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559	Cincinnati	Ohio
United States	Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)		at 16 weeks	No
Secondary	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.		at 16 weeks	No