Preschool Supplement to Clonidine in ADHD (Kiddie-CAT) | NCT00414921

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

NCT00414921

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

May 21, 2009Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

clonidine
methylphenidate
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01NS039087	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Dec 21, 2006

First Submission Date that Met QC Criteria

Dec 21, 2006

First Posted Date

Dec 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2009

Last Update Posted Date

May 21, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of CincinnatiOTHER

Collaborators

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	clonidine	Drug: clonidine
2	Active Comparator	methylphenidate	Drug: methylphenidate
3	Active Comparator	methylphenidate and clonidine	Drug: clonidine Drug: methylphenidate
4	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clonidine	Drug	Clonidine is FDA-approved for the treatment of hypertension in adults	1 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)		at 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C		Rochester	New York	14618	United States

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003000	Clonidine
D008774	Methylphenidate
C041626	5,10-dihydro-5-methylphenazine

Ancestor Terms

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided