Treatment of College Students With Attention-Deficit/Hyperactivity Disorder (ADHD) Using OROS Methylphenidate

This study has been withdrawn prior to enrollment.
(Study was not initiated due to lack of funding by the sponsor)
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00931398
First received: June 30, 2009
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

The purpose of the proposed study is to determine the effectiveness of methylphenidate HCl (Concerta) in college students with ADHD. This study will consist of 110 college students between the ages of 18 and 25 who are enrolled full-time in a local or junior college. The study consists of an 8-week double-blind, placebo-controlled trial of placebo versus methylphenidate HCl (Concerta®) followed by a 10-week extension of open label methylphenidate HCl (Concerta®).


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder (ADHD)
Drug: methylphenidate HCl (Concerta)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of College Students With ADHD Using OROS Methylphenidate

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary efficacy measures will be the self-reported CAARS DSM-IV ADHD Symptoms Total and the CAARS Inattention/Memory Problems indices (Connors et al., 1999) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary measures include CAARS subscales, Barkley Adult ADHD Rating Scale, Impairment Rating Scale, General Life Functioning, final grades and GPA, substance use and associated negative consequences. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate HCl (Concerta) Drug: methylphenidate HCl (Concerta)
Concerta 18 mg, 36 mg, 54 mg, and 72 mg q.am.
Other Name: Concerta
Placebo Comparator: Placebo Drug: Placebo
Matched placebo for all Concerta doses.

Detailed Description:

There are very few trials on drug efficacy and safety treatment performed specifically for college students with Attention-Deficit/Hyperactivity Disorder (ADHD). Although data based on the adult population can often be extrapolated and generalized to a college population, there are unique treatment demands for college students with ADHD that are not represented in day-to-day functioning of adults with ADHD. For example, although adults may be able to choose employment that capitalizes on their skill sets and tolerate ADHD-related deficits, all college students must manage intensive learning experiences in an environment that places unparalleled demands on higher order cognitive processes that are deficient with ADHD. In addition, it may be important to address the comorbidities that may be common among ADHD college students. This could range from eating disorders, depression or anxiety to alcoholism and drug abuse. For example, heavy drinking peaks in the college student years regardless of ADHD but the long-term course and underlying predispositions may be different among individuals with a history of ADHD (Molina et al., 2007). Although there are a few case studies, there are limited studies on ADHD and their comorbidities in college students perhaps because it may be a challenge to recruit a respectable sample size. Furthermore, it may be important to recognize that some college students never develop diagnosable ADHD symptoms as children, and that the signs may manifest themselves in a very harmful way during college when demands for academic rigor and organization reach their height. Given the juxtaposing conditions of academic demand, autonomy from parents, and increased opportunities for drug abuse, it becomes imperative to directly address treatment in this population. Much more research is left to be performed on this unique population of ADHD patients.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-25 years, inclusive
  • DSM-IV diagnosis of ADHD (any subtype)
  • Clinical Global Impressions scale (CGI)—Severity score of ≥4 ("Moderately ill" or higher) for ADHD

Exclusion Criteria:

  • Pregnancy or a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk
  • Abnormal liver function
  • History of pervasive developmental disorder, schizophrenia, other psychotic disorders, or eating disorders
  • Currently taking other psychotropic medications from which discontinuation would present a significant risk (we will not allow subjects with a satisfactory medication response to discontinue that medication and to participate)
  • Active substance dependence or lack of control of substance use that does not allow for safe medication administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931398

Locations
United States, Pennsylvania
Youth and Family Research Program
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Oscar G Bukstein, MD, MPH University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Oscar Bukstein, MD, MPH / Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00931398     History of Changes
Other Study ID Numbers: ConcertaATT4100
Study First Received: June 30, 2009
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014