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

  • STATUS
    Recruiting
  • End date
    Oct 11, 2022
  • participants needed
    1000
  • sponsor
    Alkermes, Inc.
Updated on 11 May 2021
antipsychotics
abilify
risperdal

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)

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.

Details
Condition Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), schizophrenia disorders
Clinical Study IdentifierNCT03919994
SponsorAlkermes, Inc.
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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