Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: clonidine (Drug); methylphenidate (Drug); placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s): Floyd R. Sallee, M.D., Ph.D., Principal Investigator, Affiliation: Children's Hospital & Medical Center
Summary
The purpose of this study is to determine the safety and efficacy of clonidine alone or in
combination with methylphenidate for children 7-12 years of age with attention-deficit,
hyperactivity disorder.
Clinical Details
Official title: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
Secondary outcome: 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
Detailed description:
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
FDA-approved 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
be safe and effective for the treatment of many ADHD symptoms. Such medicines, however, do
not cure the condition or improve all of the symptoms of ADHD, and the long-term
effectiveness of these medications is not well-known. In this study the participants will
be randomly selected to receive one of four treatments: 1.) clonidine; 2.) MPH; 3.)
clonidine and MPH; or 4.) a placebo (which is not an active medication, but a substance that
is thought to have no biological effect). The time participation in the study is 16 weeks.
Eligibility
Minimum age: 7 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children aged 7 through 12 in school.
- All subjects must meet DSM IV criteria for the diagnosis of ADHD of any subtype [21].
- Each subject must also satisfy the following criteria regarding the severity of ADHD
symptoms: 1. ADHD must be viewed as clinically significant and worthy of treatment
by medications as judged by the parent and the site investigator. Operationally,
medication treatment will be considered indicated for any subject who has ADHD
symptoms that significantly interfere with academic or social functioning and that
have not improved (or are not expected to improve) sufficiently with
non-pharmacological interventions (e. g., modifying the classroom environment,
tutoring). 2. The site investigator's rating of global functioning on the C-GAS
must yield a score of 70 or below. Scores below 70 on the C-GAS are designated as
indicating abnormal function [22]. The score of 70 corresponds to the anchor point
description: "Some difficulty in a single area, but generally functioning pretty
well."
- Screen of Intelligence using the vocabulary and block design subtests of the Wechsler
Intelligence Scale for Children-Third Edition indicates an estimated I. Q > 70.
- Informed consent/assent signed. We will not enroll any child who does not want to
participate.
- The designated school for each subject agrees to participate in the study by
completing all required questionnaires and following all specified procedures.
- The child must be able to swallow the tablets and capsules used in this study.
Exclusion Criteria:
- Subjects with tic disorder of any type or tic symptoms, a primary diagnosis of major
depression, pervasive developmental disorder, autism, any psychotic disorder, and
mental retardation (based on current DSM criteria) will be excluded. We will not
exclude subjects with obsessive-compulsive disorder, oppositional-defiant disorder or
conduct disorder.
- The presence of a known medical condition that would preclude the use of MPH or
clonidine.
- Known pregnancy. A urinary pregnancy test will be performed for all menstruating
female subjects. Female subjects of child bearing potential will be advised not to
become pregnant. In this circumstance, study medication will be tapered and
discontinued and the subject will be terminated from the study. A urinary pregnancy
test will be repeated at the end of the study. Subjects who request information
regarding possible birth control mechanisms will be referred to their primary care
physicians.
- Known presence of impaired renal function. A routine urinalysis will be performed
for each subject to exclude signs of renal failure.
- Known active cardiovascular disease/anomaly, which would be a contraindication for
the use of MPH or clonidine.
- Subjects may not receive any other medication for the treatment of ADHD. Treatment
with MPH or other stimulants must be discontinued for at least 2 weeks prior to
enrollment and treatment with other medications to treat ADHD (e. g., antidepressants,
clonidine) must be discontinued for at least 6 weeks prior to enrollment.
- Subjects may not receive any other psychotropic medication (e. g., serotonin reuptake
inhibitors), anxiolytics (e. g., clonazepam) or hypnotics. Any such medication must be
discontinued at least 6 weeks prior to enrollment.
- Previous use of MPH or clonidine will be permitted.
Locations and Contacts
SUNY Buffalo, Center For Children & Families, Buffalo, New York 14214, United States
University of Rochester, Department of Neurology, Rochester, New York 14642, United States
Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States
Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, United States
Additional Information
Starting date: September 1999
Last updated: May 20, 2009
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