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WithdrawnNCT00931398Updated Aug 24, 2012

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

A Phase 4 interventional study of methylphenidate HCl (Concerta) and Placebo in Attention-Deficit/Hyperactivity Disorder (ADHD), sponsored by University of Pittsburgh. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2012-08-24.

Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Study was not initiated due to lack of funding by the sponsor
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
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Study 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®).

Read the 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.

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder (ADHD)
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In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

Browse Hyperkinesis studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Methylphenidate HCl (Concerta)

    Drug: methylphenidate HCl (Concerta)

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Drugmethylphenidate HCl (Concerta)

    Concerta 18 mg, 36 mg, 54 mg, and 72 mg q.am.

    Also known as: Concerta

  • DrugPlacebo

    Matched placebo for all Concerta doses.

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What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Youth and Family Research Program
    Pittsburgh, Pennsylvania 15213, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00931398
Lead sponsor
University of Pittsburgh
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
First posted
Jul 2, 2009
Start date
Apr 2010
Primary completion
Apr 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Aug 24, 2012

Study contacts

Oscar G Bukstein, MD, MPH
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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