This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
426
Olanzapine + samidorphan, daily oral dosing
Daily oral dosing
Percent Change From Baseline in Body Weight at Week 12
The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
Time frame: Baseline and 12 weeks
Percentage of Subjects With ≥10% Weight Gain at Week 12
Percentage of weight gain is analyzed based on the subject's assessment status (≥10% vs \<10%) at Week 12 using a logistic regression model including treatment group, diagnosis (schizophrenia/schizophreniform disorder vs bipolar I disorder), region (US vs non-US), and baseline BMI (\<25 vs ≥25) as factors and baseline weight as covariate.
Time frame: Baseline and 12 weeks
Percentage of Subjects With ≥7% Weight Gain at Week 12
Time frame: Baseline and 12 weeks
Number of Participants Experiencing of Adverse Events (AEs)
Time frame: Up to 16 weeks
Change From Baseline in Waist Circumference at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12
Clinical Global Impression-Severity (CGI-S) Score is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. It is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "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."
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Rogers, Arkansas, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
San Diego, California, United States
Alkermes Investigational Site
Stanford, California, United States
Alkermes Investigational Site
Jacksonville, Florida, United States
Alkermes Investigational Site
North Miami, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Augusta, Georgia, United States
...and 47 more locations
Time frame: Baseline and Week 12