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A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 160mg as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
University Hills Clinical Research
Irving, Texas, United States
Start Date
November 1, 2012
Primary Completion Date
April 1, 2013
Completion Date
April 1, 2013
Last Updated
June 22, 2021
4
ACTUAL participants
SPD489 40mg
DRUG
SPD489 100mg
DRUG
SPD489 160mg
DRUG
Placebo
DRUG
Lead Sponsor
Shire
NCT07455929
NCT06740383
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