Clinical Trials Logo
  1. Home
  2. Schizophrenia
  3. NCT03919994
  4. Details
NCT03919994 Clinical Trial

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

Schizophrenia Clinical Trial

Official title:
OASIS: Observational Study of LAIs In Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03919994
Other study ID # ALKS 9072-A403N
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 28, 2019
Est. completion date January 4, 2023

Study information
Verified date February 2023
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 338
Est. completion date January 4, 2023
Est. primary completion date January 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Alkermes Investigational Site Augusta Georgia
United States Alkermes Investigational Site Austin Texas
United States Alkermes Investigational Site Beachwood Ohio
United States Alkermes Investigational Site Bel Air Maryland
United States Alkermes Investigational Site Boston Massachusetts
United States Alkermes Investigational Site Buffalo New York
United States Alkermes Investigational Site Costa Mesa California
United States Alkermes Investigational Site Dayville Connecticut
United States Alkermes Investigational Site Durant Oklahoma
United States Alkermes Investigational Site El Cajon California
United States Alkermes Investigational Site Eugene Oregon
United States Alkermes Investigational Site Fairlawn Ohio
United States Alkermes Investigational Site Fort Worth Texas
United States Alkermes Investigational Site Franklin Tennessee
United States Alkermes Investigational Site Glen Oaks New York
United States Alkermes Investigational Site Granada Hills California
United States Alkermes Investigational Site Grand Rapids Michigan
United States Alkermes Investigational Site Hialeah Florida
United States Alkermes Investigational Site Hialeah Florida
United States Alkermes Investigational Site Honolulu Hawaii
United States Alkermes Investigational Site Honolulu Hawaii
United States Alkermes Investigational Site Houston Texas
United States Alkermes Investigational Site Indianapolis Indiana
United States Alkermes Investigational Site Jamaica New York
United States Alkermes Investigational Site Kalamazoo Michigan
United States Alkermes Investigational Site Kansas City Missouri
United States Alkermes Investigational Site Lauderdale Lakes Florida
United States Alkermes Investigational Site Lawrenceville Georgia
United States Alkermes Investigational Site Lincoln Nebraska
United States Alkermes Investigational Site Manchester New Hampshire
United States Alkermes Investigational Site Miami Florida
United States Alkermes Investigational Site Miami Gardens Florida
United States Alkermes Investigational Site New York New York
United States Alkermes Investigational Site Oceanside California
United States Alkermes Investigational Site Orlando Florida
United States Alkermes Investigational Site Panama City Florida
United States Alkermes Investigational Site Panorama City California
United States Alkermes Investigational Site Poughkeepsie New York
United States Alkermes Investigational Site Raymore Missouri
United States Alkermes Investigational Site Richmond Texas
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site Salt Lake City Utah
United States Alkermes Investigational Site San Antonio Texas
United States Alkermes Investigational Site San Bernardino California
United States Alkermes Investigational Site Schaumburg Illinois
United States Alkermes Investigational Site Sioux Falls South Dakota
United States Alkermes Investigational Site Springfield Illinois
United States Alkermes Investigational Site Tallahassee Florida
United States Alkermes Investigational Site Tucson Arizona
United States Alkermes Investigational Site Tulsa Oklahoma
United States Alkermes Investigational Site Tulsa Oklahoma
United States Alkermes Investigational Site Westlake Ohio
United States Alkermes Investigational Site Wichita Falls Texas
United States Alkermes Investigational Site Wooster Ohio
United States Alkermes Investigational Site Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Schizophrenia disease history Including time (years) since diagnosis as assessed from clinical history Baseline
Primary Number of comorbid conditions at baseline Assessed from clinical history Baseline
Primary Changes in comorbid conditions The percent of patients experiencing each comorbid condition will be assessed at follow-up visits Up to 12 months
Primary Number of LAI injections Average number of injections during treatment period Up to 12 months
Primary Number of patients switching or discontinuing LAI treatment Up to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A