A Study of ALKS 3831 in Adults With Schizophrenia

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: ALKS-33; Naltrexone; Olanzapine

Criteria

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