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

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Alkermes

Status

Completed

Conditions

Schizophrenia

Study type

Observational

Funder types

Industry

Identifiers

NCT03919994
ALKS 9072-A403N

Details and patient eligibility

About

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 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.

Enrollment

338 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

338 participants in 4 patient groups

ABILIFY MAINTENA®
Description:
Subjects newly initiated
ARISTADA®
Description:
Subjects newly initiated
INVEGA SUSTENNA®
Description:
Subjects newly initiated
RISPERDAL CONSTA®
Description:
Subjects newly initiated

Trial contacts and locations

58

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Data sourced from clinicaltrials.gov

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