Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD - Full Text View

Sponsor:	University of Maryland
Collaborators:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Children's Research Institute
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00318981

Purpose

This study involves a 7 week dose-response trial of Concerta™ methylphenidate for mothers of children with ADHD who have ADHD themselves. The aim of this study is to assess the efficacy of Concerta™ in improving adult ADHD symptoms and impairments (primary outcome), as well as observed and reported parenting (secondary outcome). The researchers hypothesize that Concerta™ will significantly decrease mothers ADHD symptoms and impairment, as well as improve observed and reported parenting

Condition	Intervention	Phase
Adult ADHD	Drug: Concerta	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD

Resource links provided by NLM:

MedlinePlus related topics: Parenting

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Adult ADHD symptoms (Conners Adult ADHD Rating Scale)
Impairment ratings (CGI)
Side Effects (Pittsburgh Side Effect Scale)

Secondary Outcome Measures:

Parenting measures (Parenting Stress Index, Alabama Parenting Questionnaire, O'Leary Parenting Scale, Observed Parent Child Interaction)

Estimated Enrollment:	40
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2006

Detailed Description:

There is evidence to suggest that ADHD persists in approximately 50-65% of individuals diagnosed with the disorder during childhood. Due to the familial nature and presumed genetic etiology of this disorder, parents with ADHD are more likely to have children also diagnosed with ADHD. Accordingly, higher rates of adult ADHD have been found in parents of children with ADHD. Recent research has determined that among children with ADHD, there is a 23 times greater rate of ADHD in mothers and a 4 times greater rate of ADHD in fathers relative to parents of children without the disorder.

Research has also suggested that ADHD symptoms that persist into adulthood are impairing in many areas of an individual’s life, including their family functioning and work functioning. Spouses of ADHD adults report that their partners’ difficulties with communication, task completion, and time management negatively impact their marriages. Similarly, adult ADHD may interfere with parenting in that parents with ADHD may have trouble maintaining their attention during interactions with their children or may overreact to their children’s tantrums. However, the role of parents for children with ADHD is critical. Parents of children with ADHD both assist in the delivery of pharmacological and behavioral treatments their children. Therefore, a parent’s own ADHD symptoms may interfere with their ability to deliver these vital resources to their child.

Despite this research, little research has been conducted looking at effects of using stimulant medication to treat parents with ADHD who have children with ADHD. In fact, only one case study has examined the effects of treatment for parental ADHD on child treatment response.

The current study seeks to examine the effect of a long-acting stimulant medication (Concerta) on mothers with ADHD who have children with ADHD. Mothers and children receive a free comprehensive ADHD assessment and mothers receive a free 7 week treatment of Concerta under the supervision of a physician.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mother:

Have ADHD or problems paying attention and concentration themselves
Have a child 6-12 years old with ADHD or possible ADHD
Be the child’s biological mother

Exclusion Criteria:

Any CURRENT Axis I disorder (including major depression, psychosis, and substance use disorders) but with the exception of minor depressive or anxiety disorders
Use of Anti-depressant medication
Mothers with severe tics or Tourette’s syndrome, a history of seizures or abnormal EEGs, high blood pressure, or narrowing or blockage of the GI tract
Any women pregnant or brest-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318981

Locations

United States, Virginia
Children's National Medical Center Regional Outpatient Center
Fairfax, Virginia, United States, 22031

Sponsors and Collaborators

University of Maryland

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Children's Research Institute

Investigators

Principal Investigator:

Andre M Chronis, PhD

University of Maryland, College Park

More Information

Additional Information:

University of Maryland ADHD Program This link exits the ClinicalTrials.gov site

No publications provided by University of Maryland

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Chronis-Tuscano A, Seymour KE, Stein MA, Jones HA, Jiles CD, Rooney ME, Conlon CJ, Efron LA, Wagner SA, Pian J, Robb AS. Efficacy of osmotic-release oral system (OROS) methylphenidate for mothers with attention-deficit/hyperactivity disorder (ADHD): preliminary report of effects on ADHD symptoms and parenting. J Clin Psychiatry. 2008 Dec;69(12):1938-47. Epub 2008 Dec 2.

Study ID Numbers:	IIS-2003-023
Study First Received:	April 25, 2006
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00318981 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Maryland:

Medication trial
ADHD
Concerta
Efficacy trial

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Methylphenidate
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010