A Study of ALKS 3831 in Adults With Schizophrenia

Phase 2CompletedNCT01903837

Alkermes, Inc.347 enrolled

Overview

This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

347

Conditions

Schizophrenia

Interventions

Samidorphan (Low Dose)DRUG

Tablets taken once daily

Samidorphan (Medium Dose)DRUG

Tablets taken once daily

Samidorphan (High Dose)DRUG

Tablets taken once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 50 years, inclusive * Body mass index (BMI) of 17-30 kg/m2, inclusive * Diagnosis of schizophrenia that is clinically stable Exclusion Criteria: * Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting \<2 years * Current diagnosis of alcohol or drug use disorder, moderate or severe * Clinically significant or unstable medical illness, condition, or disorder * Pregnant or breastfeeding * Significant changes in diet or exercise regimen or plans to join a weight management program during the study * Opioid medications taken within 14 days and/or need to take opioid medication during the study period * History of hypersensitivity to or intolerance of olanzapine * Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year

Locations (61)

Outcomes

Primary Outcomes

Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score

Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.