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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.

Tracking Information
First Submitted Date April 1, 2019
First Posted Date April 18, 2019
Last Update Posted Date June 21, 2019
Actual Study Start Date March 28, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2019)
  • Schizophrenia disease history [ Time Frame: Baseline ]
    Including time (years) since diagnosis as assessed from clinical history
  • Number of comorbid conditions at baseline [ Time Frame: Baseline ]
    Assessed from clinical history
  • 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
  • Number of LAI injections [ Time Frame: Up to 12 months ]
    Average number of injections during treatment period
  • Number of patients switching or discontinuing LAI treatment [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03919994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
Official Title OASIS: Observational Study of LAIs In Schizophrenia
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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with schizophrenia who are newly initiating LAI treatment
Condition Schizophrenia
Intervention Not Provided
Study Groups/Cohorts
  • ABILIFY MAINTENA®
    Subjects newly initiated
  • ARISTADA®
    Subjects newly initiated
  • INVEGA SUSTENNA®
    Subjects newly initiated
  • RISPERDAL CONSTA®
    Subjects newly initiated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Juli Chalifour 984.208.9828 juli.chalifour@worldwide.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03919994
Other Study ID Numbers ALKS 9072-A403N
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Alkermes, Inc.
Study Sponsor Alkermes, Inc.
Collaborators Not Provided
Investigators
Study Director: Alkermes Medical Director Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date June 2019