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

Overview

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®)

Full Title of Study: “OASIS: Observational Study of LAIs In Schizophrenia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 4, 2023

Detailed Description

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.

Arms, Groups and Cohorts

  • ABILIFY MAINTENA®
    • Subjects newly initiated
  • ARISTADA®
    • Subjects newly initiated
  • INVEGA SUSTENNA®
    • Subjects newly initiated
  • RISPERDAL CONSTA®
    • Subjects newly initiated

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alkermes, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alkermes Medical Director, Study Director, Alkermes, Inc.

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