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

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ClinicalTrials.gov Identifier: NCT03919994
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

Detailed Description:
This is a non-interventional, prospective, multi-center observational cohort study. Patients at community-based 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.

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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 28, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
ABILIFY MAINTENA®
Subjects newly initiated
ARISTADA®
Subjects newly initiated
INVEGA SUSTENNA®
Subjects newly initiated
RISPERDAL CONSTA®
Subjects newly initiated



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 ]


Information from the National Library of Medicine

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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 an imminent danger to himself/herself, or was an imminent danger to himself/herself within the 2 weeks prior to enrollment.
  • Additional criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919994


Contacts
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Contact: Juli Chalifour 984.208.9828 juli.chalifour@worldwide.com

Locations
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United States, California
Alkermes Investigational Site Recruiting
Panorama City, California, United States, 91402
United States, Hawaii
Alkermes Investigational Site Recruiting
Honolulu, Hawaii, United States, 96817
United States, Missouri
Alkermes Investigational Site Recruiting
Saint Louis, Missouri, United States, 63128
United States, New York
Alkermes Investigational Site Recruiting
New York, New York, United States, 10036
United States, Ohio
Alkermes Investigational Site Recruiting
Westlake, Ohio, United States, 44145
United States, South Dakota
Alkermes Investigational Site Recruiting
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Alkermes Medical Director Alkermes, Inc.

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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: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alkermes, Inc.:
Alkermes
Schizophrenia
ARISTADA
Abilify Maintena
Invega Sustenna
Risperdal Consta
Cohort Study
Observational
Phase 4

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists