A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Launched by ALKERMES, INC. · Dec 21, 2015
Trial Information
Current as of May 28, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Has a diagnosis of chronic schizophrenia or schizoaffective disorder
- • Has demonstrated ability to tolerate aripiprazole
- • Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
- • Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
- • Additional criteria may apply
- Exclusion Criteria:
- • Is pregnant, is planning to become pregnant, or is currently breastfeeding
- • Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
- • Is a danger to himself/herself at screening or upon admission
- • Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- • Has a positive urine drug screen at screening or Day 1
- • Additional criteria may apply
About Alkermes, Inc.
Alkermes, Inc. is a biopharmaceutical company dedicated to developing innovative therapies for the treatment of central nervous system (CNS) and addiction-related disorders. With a focus on addressing unmet medical needs, Alkermes leverages its expertise in drug formulation and delivery to create effective and patient-centric solutions. The company's robust pipeline includes both proprietary and partnered programs aimed at improving the lives of individuals affected by complex and challenging conditions. Committed to scientific excellence and patient safety, Alkermes collaborates with healthcare professionals and stakeholders to advance research and bring transformative treatments to market.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cerritos, California, United States
Oakland, California, United States
Hoffman Estates, Illinois, United States
Marlton, New Jersey, United States
Lemon Grove, California, United States
Marlton, New Jersey, United States
Dallas, Texas, United States
Patients applied
Trial Officials
Robert Risinger, MD
Study Director
Alkermes, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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