Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD

NCT00318981 | Completed Phase 4

• 1 other identifier: IIS-2003-023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adult ADHD

Keywords

Medication trial; ADHD; Concerta; Efficacy trial

Outcome Measures

Primary Outcomes (3)

• Adult ADHD symptoms (Conners Adult ADHD Rating Scale)

• Impairment ratings (CGI)

• Side Effects (Pittsburgh Side Effect Scale)

Secondary Outcomes (1)

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

Interventions

Concerta DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator
• Children's National Research Institute: collaborator

Study Sites (1)

Children's National Medical Center Regional Outpatient Center

Fairfax, Virginia, 22031, United States

Location

Related Publications (1)

• 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. doi: 10.4088/jcp.v69n1213. Epub 2008 Dec 2.

  PMID: 19192455 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Andre M Chronis, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: December 1, 2004
• Study Completion: December 1, 2006
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

US (1)