Clinical trial NCT03919994: Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
Official title: OASIS: Observational Study of LAIs In Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Alkermes
Schizophrenia
ARISTADA
Abilify Maintena
Invega Sustenna
Risperdal Consta
Cohort Study
Observational
Phase 4
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia who are newly initiating LAI treatment

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®)

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.

Eligibility 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

Primary outcomes:
measure: Schizophrenia disease history
timeFrame: Baseline
measure: Number of comorbid conditions at baseline
timeFrame: Baseline
measure: Changes in comorbid conditions
timeFrame: Up to 12 months
measure: Number of LAI injections
timeFrame: Up to 12 months
measure: Number of patients switching or discontinuing LAI treatment
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Costa Mesa
country: United States
facility: Alkermes Investigational Site
state: California
city: El Cajon
country: United States
facility: Alkermes Investigational Site
state: California
city: Granada Hills
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Panorama City
country: United States
facility: Alkermes Investigational Site
state: California
city: San Bernardino
country: United States
facility: Alkermes Investigational Site
state: California
city: Dayville
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Hialeah
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami Gardens
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Panama City
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Augusta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Alkermes Investigational Site
state: Hawaii
city: Honolulu
country: United States
facility: Alkermes Investigational Site
state: Hawaii
city: Schaumburg
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Bel Air
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Boston
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Raymore
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Alkermes Investigational Site
state: Nebraska
city: Manchester
country: United States
facility: Alkermes Investigational Site
state: New Hampshire
city: Buffalo
country: United States
facility: Alkermes Investigational Site
state: New York
city: Glen Oaks
country: United States
facility: Alkermes Investigational Site
state: New York
city: Jamaica
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Alkermes Investigational Site
state: New York
city: Beachwood
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Fairlawn
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Wooster
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Durant
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Wyomissing
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Alkermes Investigational Site
state: South Dakota
city: Franklin
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Richmond
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Alkermes Investigational Site
state: Utah
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References: