Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 4NCT00931398
Treatment of College Students With Attention-Deficit/Hyperactivity Disorder (ADHD) Using OROS Methylphenidate
A Phase 4 study testing methylphenidate HCl (Concerta) in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- methylphenidate HCl (Concerta)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Youth and Family Research Program
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Treatment of College Students With ADHD Using OROS Methylphenidate
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.
- Being tested
- methylphenidate HCl (Concerta), Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate HCl (Concerta)Drug
Also called Concerta
Concerta 18 mg, 36 mg, 54 mg, and 72 mg q.am.
PlaceboDrug
Matched placebo for all Concerta doses.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate HCl (Concerta) | Experimental | Not described Receives: Drug: methylphenidate HCl (Concerta) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startApr 2010
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Why it stopped: Study was not initiated due to lack of funding by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Investigators
- Oscar G Bukstein, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931398
- Sponsor's protocol ID
- ConcertaATT4100
- Status last verified
- Aug 2012
- First submitted
- 30 Jun 2009
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of College Students With ADHD Using OROS Methylphenidate
- ClinicalTrials.gov ID
- NCT00931398
- Acronym / sponsor ID
- ConcertaATT4100
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated due to lack of funding by the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Apr 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate HCl (Concerta) | Experimental | Drug: methylphenidate HCl (Concerta) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate HCl (Concerta)Also: ConcertaConcerta 18 mg, 36 mg, 54 mg, and 72 mg q.am. | Drug | Methylphenidate HCl (Concerta) |
| PlaceboMatched placebo for all Concerta doses. | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar G Bukstein, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylphenidate HCl (Concerta) in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.