Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03919994
Recruitment Status : Active, not recruiting
First Posted : April 18, 2019
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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®)

Condition or disease
Schizophrenia

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 338 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OASIS: Observational Study of LAIs In Schizophrenia
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with schizophrenia who are newly initiating LAI treatment
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919994


Locations
Show Show 57 study locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Layout table for investigator information
Study Director: Alkermes Medical Director Alkermes, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT03919994    
Other Study ID Numbers: ALKS 9072-A403N
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alkermes, Inc.:
Alkermes
Schizophrenia
ARISTADA
Abilify Maintena
Invega Sustenna
 Risperdal Consta
Cohort Study
Observational
Phase 4
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders