A Study of ALKS 3831 in Adults With Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01903837

Run by

Alkermes, Inc.

People needed

347

Starts

2013-06-01

Expected to finish

2015-03-01

Last updated by the study team

2021-10-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 50 years, inclusive
• Body mass index (BMI) of 17-30 kg/m2, inclusive
• Diagnosis of schizophrenia that is clinically stable

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Anaheim, California, United States
• Alkermes Investigational Site — Costa Mesa, California, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Escondido, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — National City, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Pico Rivera, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — New Britain, Connecticut, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Bradenton, Florida, United States
• Alkermes Investigational Site — Fort Lauderdale, Florida, United States
• Alkermes Investigational Site — Gainesville, Florida, United States
• Alkermes Investigational Site — Kissimmee, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — Oakland Park, Florida, United States
• Alkermes Investigational Site — Orlando, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Decatur, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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