This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
403
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
Time frame: 4 weeks
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4.
Time frame: 4 weeks
Incidence of Adverse Events
Time frame: Approximately 4 weeks
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Alkermes Investigational Site
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