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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03919994

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted May 4, 2021

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
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
  • Study Type: Observational
  • Estimated Enrollment: 1000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: OASIS: Observational Study of LAIs In Schizophrenia
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: October 2022
Outcome Measures
  • 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
  • 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
Contacts

Contact: Senior Director, Global Clinical Services 888-235-8008 (US Only) clinicaltrials@alkermes.com

Contact: Senior Director, Global Clinical Services 1-571-599-2702 (Global) clinicaltrials@alkermes.com

Locations
Show 57 Study Locations
Sponsors and Collaborators

Alkermes, Inc.

Investigators

Study Director: Alkermes Medical Director Alkermes, Inc.

More Information
  • Responsible Party: Alkermes, Inc.
  • ClinicalTrials.gov Identifier: NCT03919994 History of Changes
  • Other Study ID Numbers: ALKS 9072-A403N
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: May 4, 2021
  • Last Verified: May 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Alkermes, Inc.: Alkermes
    Schizophrenia
    ARISTADA
    Abilify Maintena
    Invega Sustenna
    Risperdal Consta
    Cohort Study
    Observational
    Phase 4
  • Additional relevant MeSH terms: Schizophrenia