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CompletedNCT01552902

Safety study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in ADHD

This study is completed in the United States, in Canada, in Germany, .... It is testing SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, for ADHD.

ADHDDrugFrom 13 Years to 17 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether Lisdexamfetamine dimesylate may be useful for adolescents experiencing ADHD.

What would participation involve?

Participants may receive Lisdexamfetamine dimesylate, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Canada, in Germany, and in Hungary.

Who is it mainly for?

This study appears to be mainly for adolescents with ADHD. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: April 3, 2012
Recruitment status
Completed
Enrollment listed in the registry
549
Sponsor
Shire
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Locations
United States, Canada, Germany, ...
Age range
From 13 Years to 17 Years
Official registry ID
NCT01552902
Official title
A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

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Study ID: NCT01552902. We help you review the study, but cannot decide medical eligibility.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Canada · 2 sites
  • True North Clinical Research
    Kentville, Nova Scotia
    Site status: Not listed — confirm with the team
  • The Kids Clinic
    Whitby, Ontario
    Site status: Not listed — confirm with the team
Germany · 6 sites
  • Schwerpunktpraxis fur Entwicklung und Lernen
    Bamberg
    Site status: Not listed — confirm with the team
  • Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
    Frankfurt
    Site status: Not listed — confirm with the team
  • Universitatsklinikum Freiburg
    Freiburg im Breisgau
    Site status: Not listed — confirm with the team
  • Kinderarztpraxis Dr. Kaiser und Dr. MarineBe
    Hamburg
    Site status: Not listed — confirm with the team
  • Zentralinstitut fur Seelische Gesundheit
    Mannheim
    Site status: Not listed — confirm with the team
  • Medizinisches Studienzentrum Wurzburg
    Würzburg
    Site status: Not listed — confirm with the team
Hungary · 4 sites
  • Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia
    Budapest
    Site status: Not listed — confirm with the team
  • Bekes Megyei Pandy Kalman Korhaz
    Gyula
    Site status: Not listed — confirm with the team
  • Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek
    Pécs
    Site status: Not listed — confirm with the team
  • Szegedi Tudomanyegyetem
    Szeged
    Site status: Not listed — confirm with the team
Sweden · 2 sites
  • Gillbergcentrum
    Gothenburg
    Site status: Not listed — confirm with the team
  • PRIMA Barn-och Vuxenpsykiatri Jarva
    Spånga
    Site status: Not listed — confirm with the team
United States · 81 sites
  • Harmonex Neuroscience Research, Inc.
    Dothan, Alabama
    Site status: Not listed — confirm with the team
  • Center for Advanced Improvement
    Tucson, Arizona
    Site status: Not listed — confirm with the team
  • Clinical Study Centers, LLC
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Shanti Clinical Trials
    Colton, California
    Site status: Not listed — confirm with the team
  • Sun Valley Research Center
    Imperial, California
    Site status: Not listed — confirm with the team
  • Synergy Clinical Research Center
    National City, California
    Site status: Not listed — confirm with the team
  • Pacific Sleep Medicine, A Medical Corporation
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Neuropsychiatric Research Center for Orange County
    Orange, California
    Site status: Not listed — confirm with the team
  • Peninsula Research Associates
    Rolling Hills Estates, California
    Site status: Not listed — confirm with the team
  • PCSD - Feighner Research
    San Diego, California
    Site status: Not listed — confirm with the team
  • University of California, San Francisco
    San Francisco, California
    Site status: Not listed — confirm with the team
  • Encompass Clinical Research
    Spring Valley, California
    Site status: Not listed — confirm with the team
  • Elite Clinical Trials
    Wildomar, California
    Site status: Not listed — confirm with the team
  • IMMUNOe International Research Center
    Centennial, Colorado
    Site status: Not listed — confirm with the team
  • MCB Clinical Research Centers, LLC
    Colorado Springs, Colorado
    Site status: Not listed — confirm with the team
  • Coastal Connecticut Research, LLC
    New London, Connecticut
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center, LLC
    Bradenton, Florida
    Site status: Not listed — confirm with the team
  • Amedica Research Institute, Inc
    Hialeah, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Sarkis Clinical Trials
    Lake City, Florida
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center, LLC
    Maitland, Florida
    Site status: Not listed — confirm with the team
  • Prevention & Strengthening Solutions, Inc.
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Scientific Clinical Research, Inc.
    North Miami, Florida
    Site status: Not listed — confirm with the team
  • Medical Research Group of Central Florida
    Orange City, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Compass Research, LLC
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Miami Research Associates
    South Miami, Florida
    Site status: Not listed — confirm with the team
  • Stedman Clinical Trials
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Institute of Medicine & Research, Inc
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Clinical Research Center, University of Illinois at Chicago
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Capstone Clinical Research
    Libertyville, Illinois
    Site status: Not listed — confirm with the team
  • Baber Research Group
    Naperville, Illinois
    Site status: Not listed — confirm with the team
  • Pedia Research, LLC
    Newburgh, Indiana
    Site status: Not listed — confirm with the team
  • Psychiatric Associates
    Overland Park, Kansas
    Site status: Not listed — confirm with the team
  • Pedia Research, LLC
    Owensboro, Kentucky
    Site status: Not listed — confirm with the team
  • Louisiana Resarch Associates, Inc.
    New Orleans, Louisiana
    Site status: Not listed — confirm with the team
  • Marc Hertzman, MD, PC
    Rockville, Maryland
    Site status: Not listed — confirm with the team
  • Rochester Center for Behavioral Medicine
    Rochester Hills, Michigan
    Site status: Not listed — confirm with the team
  • Clinical Neurophysiology Services, PC
    Sterling Heights, Michigan
    Site status: Not listed — confirm with the team
  • Behavioral Medical Center - Troy
    Troy, Michigan
    Site status: Not listed — confirm with the team
  • Comprehensive Psychiatric Associates
    Gladstone, Missouri
    Site status: Not listed — confirm with the team
  • Psychiatric Care & Research Center
    O'Fallon, Missouri
    Site status: Not listed — confirm with the team
  • St. Charles Psychiatric Associates - Midwest Research Group
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Premier Psychiatric Research Institute, LLC
    Lincoln, Nebraska
    Site status: Not listed — confirm with the team
  • University of Nebraska Medical Center Dept Of Psychiatry
    Omaha, Nebraska
    Site status: Not listed — confirm with the team
  • Center for Psychiatry & Behavioral Medicine, Inc.
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • Center for Emotional Fitness
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • The NeuroCognitive Institute
    Mount Arlington, New Jersey
    Site status: Not listed — confirm with the team
  • Albuquerque Neuroscience, Inc.
    Albuquerque, New Mexico
    Site status: Not listed — confirm with the team
  • Brain Resource Center
    New York, New York
    Site status: Not listed — confirm with the team
  • Mount Sinai School of Medicine/Dept of Psychiaatry
    New York, New York
    Site status: Not listed — confirm with the team
  • Duke University medical Center/ Duke ADHD Program
    Durham, North Carolina
    Site status: Not listed — confirm with the team
  • PMG Research of Wilmington
    Wilmington, North Carolina
    Site status: Not listed — confirm with the team
  • University of Cincinnati College of Medicine/UCPC
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • The Ohio State University Nisonger Center
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Tulsa Clinical Research, LLC
    Tulsa, Oklahoma
    Site status: Not listed — confirm with the team
  • Cyn3rgy Research
    Gresham, Oregon
    Site status: Not listed — confirm with the team
  • Oregon Center for Clinical Investigations Inc
    Portland, Oregon
    Site status: Not listed — confirm with the team
  • Summit Research Network
    Portland, Oregon
    Site status: Not listed — confirm with the team
  • Oregon Center for Clinical Investigations, Inc
    Salem, Oregon
    Site status: Not listed — confirm with the team
  • University Services
    West Chester, Pennsylvania
    Site status: Not listed — confirm with the team
  • Omega Medical Research
    Warwick, Rhode Island
    Site status: Not listed — confirm with the team
  • Rainbow Research, Inc.
    Barnwell, South Carolina
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • FutureSearch Trials of Dallas, LP
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Research Across America/Psychiatric Medical Associates
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Bayou City Research
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Claghorn-Lesem Research Clinic, Ltd.
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Clinical Trial Network
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Texas Center for Drug Development, Inc.
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Red Oak Psychiatry Associates, PA
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Houston Clinical Trials, LLC
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Westex Clinical Investigations
    Lubbock, Texas
    Site status: Not listed — confirm with the team
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Univ of Texas Health Science Center at San Antonio
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Ericksen Research and Development - Westside Medical
    Clinton, Utah
    Site status: Not listed — confirm with the team
  • University of Virginia Child and Family Psychiatry Clinic
    Charlottesville, Virginia
    Site status: Not listed — confirm with the team
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Not listed — confirm with the team
  • Eastside Thereapeutic Resource
    Kirkland, Washington
    Site status: Not listed — confirm with the team
  • Summit Research Network (Seattle), LLC
    Seattle, Washington
    Site status: Not listed — confirm with the team
  • Rockwood Clinic, P.S.
    Spokane, Washington
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with adhd. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, Placebo. Phase 4 studies usually happen after treatment approval, to monitor real-world use.

Who might this study be for?

This study may concern people with adhd; age range: From 13 Years to 17 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Shire, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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