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A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 14, 2009
Primary Completion Date
January 20, 2011
Completion Date
January 20, 2011
Last Updated
June 9, 2021
92
ACTUAL participants
SPD489 (lisdexamfetamine dimesylate)
DRUG
Placebo matching SPD489 (lisdexamfetamine dimesylate)
DRUG
Lead Sponsor
Shire
Data Source & Attribution
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