Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children

NCT00031395 | Completed Phase 3 DMC

• 1 other identifier: R01NS039087
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; clonidine; methylphenidate; MPH

Outcome Measures

Primary Outcomes (1)

• Efficacy outcome was 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

Drug: clonidine

2

ACTIVE COMPARATOR

Drug: methylphenidate

3

ACTIVE COMPARATOR

Drug: clonidine; Drug: methylphenidate

4

PLACEBO COMPARATOR

Other: placebo

Interventions

clonidine DRUG

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

1; 3

methylphenidate DRUG

MPH is FDA-approved for the treatment of ADHD symptoms in children.

Also known as: MPH

2; 3

placebo OTHER

an inactive substance

4

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (4)

SUNY Buffalo, Center For Children & Families

Buffalo, New York, 14214, United States

Location

University of Rochester, Department of Neurology

Rochester, New York, 14642, United States

Location

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

• Cannon M, Pelham WH, Sallee FR, Palumbo DR, Bukstein O, Daviss WB. Effects of clonidine and methylphenidate on family quality of life in attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):511-7. doi: 10.1089/cap.2009.0008.

  PMID: 19877975 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Clonidine; Methylphenidate; 5,10-dihydro-5-methylphenazine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Floyd R. Sallee, M.D., Ph.D.

  Children's Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2002
• First Posted: March 5, 2002
• Study Start: September 1, 1999
• Study Completion: June 1, 2007
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

US (4)