Trial Outcomes & Findings for Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder (NCT NCT03187769)

The Full Analysis Set (FAS) includes all subjects in the Safety Population who have at least 1 post-baseline weight assessment. For the secondary efficacy endpoint, the LS mean (±SE \[95% CI\]) change from baseline in CGI S score was measured within the ALKS 3831 Group 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

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.

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."