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

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Treatment of College Students With ADHD Using OROS Methylphenidate

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00931398
• Other study ID #: ConcertaATT4100
• Status: Withdrawn
• Phase: Phase 4
• First received: June 30, 2009
• Last updated: August 23, 2012
• Start date: April 2010
• Est. completion date: April 2010

Study information

• Verified date: August 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Drug:
• methylphenidate HCl (Concerta)
Concerta 18 mg, 36 mg, 54 mg, and 72 mg q.am.
• Placebo
Matched placebo for all Concerta doses.

Locations

Country	Name	City	State
United States	Youth and Family Research Program	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		8 weeks	No
Secondary	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.		8 weeks	No

External Links

•   study site web page