Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)

Study Overview
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Brief Summary
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The objectives of this study are to describe characteristics, treatment patterns, and outcomes of patients with schizophrenia newly initiated on 1 of 4 FDA-approved atypical Long Acting Injectable (LAI) antipsychotics (ABILIFY MAINTENA®, ARISTADA®, INVEGA SUSTENNA® or RISPERDAL CONSTA®)

Detailed Description
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This is a non-interventional, prospective, multi-center observational cohort study. Patients at behavioral health clinics will be enrolled and evaluated by health care professionals (e.g., psychiatrists) according to the standard of care. All patients will be followed for approximately 12 months from their enrollment visit.

Official Title
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OASIS: Observational Study of LAIs In Schizophrenia

Conditions
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Schizophrenia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to speak, read and understand English Diagnosis of schizophrenia as defined by the treating clinician Newly initiating treatment with 1 of 4 atypical Long Acting Injectables (LAIs): Abilify Maintena, Aristada, Invega Sustenna, or Risperdal Consta) Additional criteria may apply Exclusion Criteria: Currently participating or planning to participate in an interventional clinical study, or has completed participation in an interventional clinical study within 30 days before enrollment In the opinion of the investigator, is currently an imminent danger to himself/herself. [Note: A prior history of suicidal ideation or suicidal attempt is not exclusionary.] Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ABILIFY MAINTENA®<br>Subjects newly initiated | |
| ARISTADA®<br>Subjects newly initiated | |
| INVEGA SUSTENNA®<br>Subjects newly initiated | |
| RISPERDAL CONSTA®<br>Subjects newly initiated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schizophrenia disease history | Including time (years) since diagnosis as assessed from clinical history | Baseline | 
| Number of comorbid conditions at baseline | Assessed from clinical history | Baseline | 
| Changes in comorbid conditions | The percent of patients experiencing each comorbid condition will be assessed at follow-up visits | Up to 12 months | 
| Number of LAI injections | Average number of injections during treatment period | Up to 12 months | 
| Number of patients switching or discontinuing LAI treatment |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, Schizophrenia, ARISTADA, Abilify Maintena, Invega Sustenna, Risperdal Consta, Cohort Study, Observational, Phase 4