The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
512
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Seoul, South Korea
Unnamed facility
Taipei, Taiwan
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
Time frame: Baseline and Week 6
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).
Time frame: Baseline and Week 6
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Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.