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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2023

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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