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

February 1, 2023 updated by: Alkermes, Inc.

OASIS: Observational Study of LAIs In Schizophrenia

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®)

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Alkermes Investigational Site
    • California
      • Costa Mesa, California, United States, 92626
        • Alkermes Investigational Site
      • El Cajon, California, United States, 92021
        • Alkermes Investigational Site
      • Granada Hills, California, United States, 91334
        • Alkermes Investigational Site
      • Oceanside, California, United States, 92054
        • Alkermes Investigational Site
      • Panorama City, California, United States, 91402
        • Alkermes Investigational Site
      • San Bernardino, California, United States, 92404
        • Alkermes Investigational Site
    • Connecticut
      • Dayville, Connecticut, United States, 06241
        • Alkermes Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Alkermes Investigational Site
      • Hialeah, Florida, United States, 33016
        • Alkermes Investigational Site
      • Lauderdale Lakes, Florida, United States, 33319
        • Alkermes Investigational Site
      • Miami, Florida, United States, 33136
        • Alkermes Investigational Site
      • Miami Gardens, Florida, United States, 33014
        • Alkermes Investigational Site
      • Orlando, Florida, United States, 32803
        • Alkermes Investigational Site
      • Panama City, Florida, United States, 32405
        • Alkermes Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Alkermes Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Alkermes Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Alkermes Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Alkermes Investigational Site
      • Honolulu, Hawaii, United States, 96826
        • Alkermes Investigational Site
    • Illinois
      • Schaumburg, Illinois, United States, 60194
        • Alkermes Investigational Site
      • Springfield, Illinois, United States, 62702
        • Alkermes Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Alkermes Investigational Site
    • Maryland
      • Bel Air, Maryland, United States, 21015
        • Alkermes Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Alkermes Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Alkermes Investigational Site
      • Kalamazoo, Michigan, United States, 49008
        • Alkermes Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Alkermes Investigational Site
      • Raymore, Missouri, United States, 64083
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63118
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Alkermes Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Alkermes Investigational Site
    • New Hampshire
      • Manchester, New Hampshire, United States, 03101
        • Alkermes Investigational Site
    • New York
      • Buffalo, New York, United States, 14215
        • Alkermes Investigational Site
      • Glen Oaks, New York, United States, 11004
        • Alkermes Investigational Site
      • Jamaica, New York, United States, 11418
        • Alkermes Investigational Site
      • New York, New York, United States, 10032
        • Alkermes Investigational Site
      • Poughkeepsie, New York, United States, 12603
        • Alkermes Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Alkermes Investigational Site
      • Fairlawn, Ohio, United States, 44333
        • Alkermes Investigational Site
      • Westlake, Ohio, United States, 44145
        • Alkermes Investigational Site
      • Wooster, Ohio, United States, 44691
        • Alkermes Investigational Site
    • Oklahoma
      • Durant, Oklahoma, United States, 74701
        • Alkermes Investigational Site
      • Tulsa, Oklahoma, United States, 74114
        • Alkermes Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Alkermes Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Alkermes Investigational Site
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Alkermes Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Alkermes Investigational Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78746
        • Alkermes Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77074
        • Alkermes Investigational Site
      • Richmond, Texas, United States, 77407
        • Alkermes Investigational Site
      • San Antonio, Texas, United States, 78229
        • Alkermes Investigational Site
      • Wichita Falls, Texas, United States, 76306
        • Alkermes Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with schizophrenia who are newly initiating LAI treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ABILIFY MAINTENA®
Subjects newly initiated
ARISTADA®
Subjects newly initiated
INVEGA SUSTENNA®
Subjects newly initiated
RISPERDAL CONSTA®
Subjects newly initiated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schizophrenia disease history
Time Frame: Baseline
Including time (years) since diagnosis as assessed from clinical history
Baseline
Number of comorbid conditions at baseline
Time Frame: Baseline
Assessed from clinical history
Baseline
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
Up to 12 months
Number of LAI injections
Time Frame: Up to 12 months
Average number of injections during treatment period
Up to 12 months
Number of patients switching or discontinuing LAI treatment
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2019

Primary Completion (ACTUAL)

January 4, 2023

Study Completion (ACTUAL)

January 4, 2023

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (ACTUAL)

April 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 9072-A403N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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