Status:
COMPLETED
A Study of ALKS 3831 in Adults With Schizophrenia
Lead Sponsor:
Alkermes, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 vi...
Eligibility Criteria
Inclusion
- Age 18 to 50 years, inclusive
- Body mass index (BMI) of 17-30 kg/m2, inclusive
- Diagnosis of schizophrenia that is clinically stable
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01903837
Start Date
June 1 2013
End Date
March 1 2015
Last Update
October 6 2021
Active Locations (61)
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1
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
2
Alkermes Investigational Site
Anaheim, California, United States, 92805
3
Alkermes Investigational Site
Costa Mesa, California, United States, 92626
4
Alkermes Investigational Site
Culver City, California, United States, 90230