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

NCT00931398 | Withdrawn Phase 4 DMC

• 1 other identifier: ConcertaATT4100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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®).

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

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)

  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.

  8 weeks

Study Arms (2)

Methylphenidate HCl (Concerta)

EXPERIMENTAL

Drug: methylphenidate HCl (Concerta)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

methylphenidate HCl (Concerta) DRUG

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

Also known as: Concerta

Methylphenidate HCl (Concerta)

Placebo DRUG

Matched placebo for all Concerta doses.

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Youth and Family Research Program

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• study site web page

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Oscar G Bukstein, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 2, 2009
• Study Start: April 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

US (1)