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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT03919994
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-03-28
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Salt Lake City, Utah, United States