Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
NCT ID: NCT00922272
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2009-09-14
2011-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPD489 (Lisdexamfetamine dimesylate)
SPD489 (lisdexamfetamine dimesylate)
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Placebo
Placebo
Placebo matching SPD489 (lisdexamfetamine dimesylate)
oral, once daily
Interventions
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SPD489 (lisdexamfetamine dimesylate)
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Placebo matching SPD489 (lisdexamfetamine dimesylate)
oral, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically stable Schizophrenia and predominant negative symptoms
* Taking a stable dose of antipsychotic medication
Exclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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K&S Professional Research Services
Little Rock, Arkansas, United States
South Coast Clinical Trials
Anaheim, California, United States
Omega Clinical Trials
Anaheim, California, United States
Clinical Innovations
Costa Mesa, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Apostle Clinical Trials, Inc.
Long Beach, California, United States
Excell Research, Inc.
Oceanside, California, United States
Southcoast Clinical Trials
San Bernardino, California, United States
CNRI San Diego & Los Angeles
San Diego, California, United States
Affiliated Research Institute
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Accurate Clinical Trials
Kissimmee, Florida, United States
Behavioral Clinical Research, INC
Lauderhill, Florida, United States
Segal Institute for Clinical Research (Miami)
North Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Comprehensive NeuroScience
Atlanta, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
J. Gary Booker, MD, APMC
Shreveport, Louisiana, United States
CRI Worldwide, LLC.
Willingboro, New Jersey, United States
Advanced Bio-Behavioral Sciences
Elmsford, New York, United States
Comprehensive Neuroscience, Inc.
Hollis, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Community Clinical Research, Inc.
Austin, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
Countries
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References
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Lasser RA, Dirks B, Nasrallah H, Kirsch C, Gao J, Pucci ML, Knesevich MA, Lindenmayer JP. Adjunctive lisdexamfetamine dimesylate therapy in adult outpatients with predominant negative symptoms of schizophrenia: open-label and randomized-withdrawal phases. Neuropsychopharmacology. 2013 Oct;38(11):2140-9. doi: 10.1038/npp.2013.111. Epub 2013 May 8.
Related Links
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FDA Recall Information
Other Identifiers
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SPD489-204
Identifier Type: -
Identifier Source: org_study_id
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