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OpenTrials
Completed

NCT Number: NCT03919994

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

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®)

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alkermes Investigational Site, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Schizophrenia disease history

    Time frame: Baseline

    Including time (years) since diagnosis as assessed from clinical history

  2. Number of comorbid conditions at baseline

    Time frame: Baseline

    Assessed from clinical history

  3. 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

  4. Number of LAI injections

    Time frame: Up to 12 months

    Average number of injections during treatment period

  5. Number of patients switching or discontinuing LAI treatment

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

OASIS: Observational Study of LAIs In Schizophrenia

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2019
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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