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This study aims to better understand the effectiveness of TV-44749 (a subcutaneous long-acting injectable olanzapine suspension) in adults with schizophrenia. It will examine health-related outcomes, such as hospital visits, clinical assessments, and healthcare-related costs, before and after starting TV-44749. 

This is a non-interventional, observational study. This means that healthcare professionals will not change patient treatment plans for the purposes of the study. All care and treatment decisions are made as part of routine clinical practice. 

In an observational study, researchers collect information about health and treatment as it is documented during usual care. There are no additional study-required treatments, procedures, or visits. With patient permission, some information about healthcare use and related costs may be collected from external sources such as existing healthcare records or databases.  

If patients choose to participate, their health information will be followed for up to 12 months after starting TV-44749. The study will also look at information from patients’ medical records from up to 12 months before beginning treatment, with a minimum requirement of 6 months of retrospective data (ie, data that has already been collected) to participate in the study. 

No. The study does not require additional visits, tests, or procedures beyond what a healthcare professional would normally recommend as part of standard care. 

No. Patient treatment, including starting, stopping, or adjusting medication, is decided entirely by the patient and healthcare professional, independent of the study. 

Information collected will include details from routine medical care, such as: 

• Healthcare visits, including hospitalizations or emergency care  
• Clinical assessments of symptoms and daily functioning  
• How the treatment is used over time (for example, duration or any changes)  
• Safety-related information, such as side effects or other health events documented during routine care  
• General healthcare use and related information recorded as part of standard practice  

No additional tests or assessments are required specifically for the study. 

In some cases, and only with patient consent where permitted, additional healthcare information may be collected from existing records or databases to evaluate the impact of TV-44749 on healthcare resource utilization and costs. 

There are no required study visits. Information is collected during regular healthcare appointments, which are scheduled based on usual care. Patients are expected to have approximately monthly routine visits, consistent with the approved dosing schedule for TV-44749. Data from routine visits will be summarized and analyzed at months 3, 6, and 12 after initiation of TV-44749. Patients can remain in the study even if they have missed or delayed visits. 

If patients stop the treatment, their participation in the study can continue and information will still be collected from routine care for up to 12 months after the initiation date, unless patients choose to withdraw from the study.  

Yes. Taking part in this study is completely voluntary. Patients may decide not to participate or to withdraw from the study at any time, for any reason. This decision will not affect the patient’s medical care. 

Patient privacy, including identity and personal medical information, will be maintained at all times. Patients will not be identified by their names, but by an identification code. Data collected for the study will be protected and managed securely. Personal medical information will always be treated as confidential. Additional safeguards will ensure compliance with applicable global, regional, and national privacy laws.

Patients may want to consider how their health information will be used, the length of time their data may be followed, and any questions they have about the study. Speaking with their healthcare professional or someone they trust may help them make an informed decision.