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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931398
Recruitment Status : Withdrawn (Study was not initiated due to lack of funding by the sponsor)
First Posted : July 2, 2009
Last Update Posted : August 24, 2012
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder (ADHD) Drug: methylphenidate HCl (Concerta) Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of College Students With ADHD Using OROS Methylphenidate
Study Start Date : April 2010
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: Methylphenidate HCl (Concerta) Drug: methylphenidate HCl (Concerta)
Concerta 18 mg, 36 mg, 54 mg, and 72 mg
Other Name: Concerta

Placebo Comparator: Placebo Drug: Placebo
Matched placebo for all Concerta doses.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931398

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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
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Principal Investigator: Oscar G Bukstein, MD, MPH University of Pittsburgh
Additional Information:
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Responsible Party: Oscar Bukstein, MD, MPH / Professor, University of Pittsburgh Identifier: NCT00931398    
Other Study ID Numbers: ConcertaATT4100
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents