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

Conditions

Schizophrenia

Keywords

Alkermes, Schizophrenia, ARISTADA, Abilify Maintena, Invega Sustenna, Risperdal Consta, Cohort Study, Observational, Phase 4

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.

Weiden PJ, Strand LN, Doane MJ, Arevalo C, McGrory JA, Achtyes ED, Harvey PD, Kane JM, Saklad SR, Trotter J, Velligan DI.

2025-09-23

10.2147/ndt.s528018

Changes in Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics (LAIs), Including Telepsychiatry Use, During the COVID-19 Pandemic.

Haider B, O'Sullivan AK, Bessonova L, Keane E, Achtyes E, Harvey PD, Kane JM, Saklad SR, Trotter JP, Claxton A, Polak T, McGrory J, Noori W, Sikora Kessler A, Yarlas A, Velligan D.

2023-03-172 citations

10.2147/ndt.s394220

Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics and Telepsychiatry Use During COVID-19 Pandemic

Leona Bessonova, Elizabeth Keane, Eric Achtyes, Philip D. Harvey, John M. Kane et al. (16 authors)

CNS Spectrums2022-04-012 citations

10.1017/s1092852922000256

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Number of LAI injections	Up to 12 months	Average number of injections during treatment period
Number of patients switching or discontinuing LAI treatment	Up to 12 months	—
Schizophrenia disease history	Baseline	Including time (years) since diagnosis as assessed from clinical history
Number of comorbid conditions at baseline	Baseline	Assessed from clinical history
Changes in comorbid conditions	Up to 12 months	The percent of patients experiencing each comorbid condition will be assessed at follow-up visits

Countries

United States

Outcome results