NCT00414921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 21, 2009

Status Verified

December 1, 2007

First QC Date

December 21, 2006

Last Update Submit

May 20, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention deficit hyperactivity disorderADHDclonidinemethylphenidateMPH

Outcome Measures

Primary Outcomes (1)

  • change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)

    at 16 weeks

Secondary Outcomes (1)

  • 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

Study Arms (4)

1

ACTIVE COMPARATOR

clonidine

Drug: clonidine

2

ACTIVE COMPARATOR

methylphenidate

Drug: methylphenidate

3

ACTIVE COMPARATOR

methylphenidate and clonidine

Drug: clonidineDrug: methylphenidate

4

PLACEBO COMPARATOR
Other: placebo

Interventions

clonidineDRUG

Clonidine is FDA-approved for the treatment of hypertension in adults

13
methylphenidateDRUG

Methylphenidate is known to safely and effectively treat many ADHD symptoms.

Also known as: MPH
23
placeboOTHER

inactive substance

4

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C

Rochester, New York, 14618, United States

Location

University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559

Cincinnati, Ohio, 45267-0559, United States

Location

Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

ClonidineMethylphenidate5,10-dihydro-5-methylphenazine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidines

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

September 1, 2003

Study Completion

June 1, 2007

Last Updated

May 21, 2009

Record last verified: 2007-12

Locations

US(3)