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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00931398 |
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 IV |
| 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 |
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | April 2013 (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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Heidi Kipp, M.Ed. | 412-246-5661 | kipphl@upmc.edu |
| Contact: Tracey Wilson | 412-246-5673 | wilsontk@upmc.edu |
| United States, Pennsylvania | |
| Youth and Family Research Program | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Heidi L Kipp, M.Ed. 412-246-5661 kipphl@upmc.edu | |
| Contact: Tracey K Wilson 412-246-5673 wilsontk@upmc.edu | |
| Principal Investigator: Oscar G Bukstein, MD, MPH | |
| Sub-Investigator: Brooke SG Molina, Ph.D. | |
| Sub-Investigator: Brian T Wymbs, Ph.D. | |
| Sub-Investigator: Srihari S Bangalore, MD | |
| Principal Investigator: | Oscar G Bukstein, MD, MPH | University of Pittsburgh |
More Information
| 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: | January 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
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 |