SchizophreniaNCT03919994
Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
An observational study of Schizophrenia, run by Alkermes, Inc. at 57 sites in United States.
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®) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 338 participants
- Where
- 57 sitesUnited States
- Study dates
- 28 Mar 2019to 4 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with schizophrenia who are newly initiating LAI treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Alkermes Investigational Site
Augusta, Georgia, 30912
Alkermes Investigational Site
Austin, Texas, 78746
Alkermes Investigational Site
Beachwood, Ohio, 44122
Alkermes Investigational Site
Bel Air, Maryland, 21015
Alkermes Investigational Site
Boston, Massachusetts, 02114
Alkermes Investigational Site
Buffalo, New York, 14215
Alkermes Investigational Site
Costa Mesa, California, 92626
Alkermes Investigational Site
Dayville, Connecticut, 06241
Alkermes Investigational Site
Durant, Oklahoma, 74701
Alkermes Investigational Site
El Cajon, California, 92021
Alkermes Investigational Site
Eugene, Oregon, 97401
Alkermes Investigational Site
Fairlawn, Ohio, 44333
Alkermes Investigational Site
Fort Worth, Texas, 76104
Alkermes Investigational Site
Franklin, Tennessee, 37067
Alkermes Investigational Site
Glen Oaks, New York, 11004
Alkermes Investigational Site
Granada Hills, California, 91334
Alkermes Investigational Site
Grand Rapids, Michigan, 49503
Alkermes Investigational Site
Hialeah, Florida, 33012
Alkermes Investigational Site
Hialeah, Florida, 33016
Alkermes Investigational Site
Honolulu, Hawaii, 96817
Alkermes Investigational Site
Honolulu, Hawaii, 96826
Alkermes Investigational Site
Houston, Texas, 77074
Alkermes Investigational Site
Indianapolis, Indiana, 46202
Alkermes Investigational Site
Jamaica, New York, 11418
Alkermes Investigational Site
Kalamazoo, Michigan, 49008
Alkermes Investigational Site
Kansas City, Missouri, 64108
Alkermes Investigational Site
Lauderdale Lakes, Florida, 33319
Alkermes Investigational Site
Lawrenceville, Georgia, 30046
Alkermes Investigational Site
Lincoln, Nebraska, 68526
Alkermes Investigational Site
Manchester, New Hampshire, 03101
Alkermes Investigational Site
Miami, Florida, 33136
Alkermes Investigational Site
Miami Gardens, Florida, 33014
Alkermes Investigational Site
New York, New York, 10032
Alkermes Investigational Site
Oceanside, California, 92054
Alkermes Investigational Site
Orlando, Florida, 32803
Alkermes Investigational Site
Panama City, Florida, 32405
Alkermes Investigational Site
Panorama City, California, 91402
Alkermes Investigational Site
Poughkeepsie, New York, 12603
Alkermes Investigational Site
Raymore, Missouri, 64083
Alkermes Investigational Site
Richmond, Texas, 77407
Alkermes Investigational Site
Salt Lake City, Utah, 84105
Alkermes Investigational Site
San Antonio, Texas, 78229
Alkermes Investigational Site
San Bernardino, California, 92404
Alkermes Investigational Site
Schaumburg, Illinois, 60194
Alkermes Investigational Site
Sioux Falls, South Dakota, 57104
Alkermes Investigational Site
Springfield, Illinois, 62702
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
St Louis, Missouri, 63128
Alkermes Investigational Site
St Louis, Missouri, 63141
Alkermes Investigational Site
Tallahassee, Florida, 32308
Alkermes Investigational Site
Tucson, Arizona, 85719
Alkermes Investigational Site
Tulsa, Oklahoma, 74114
Alkermes Investigational Site
Tulsa, Oklahoma, 74136
Alkermes Investigational Site
Westlake, Ohio, 44145
Alkermes Investigational Site
Wichita Falls, Texas, 76306
Alkermes Investigational Site
Wooster, Ohio, 44691
Alkermes Investigational Site
Wyomissing, Pennsylvania, 19610
About this study
Official title: OASIS: Observational Study of LAIs In Schizophrenia
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®)
Read the 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.
- Conditions
- Schizophrenia
- Keywords
- Alkermes, Schizophrenia, ARISTADA, Abilify Maintena, Invega Sustenna, Risperdal Consta, Cohort Study, Observational, Phase 4
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABILIFY MAINTENA® | Subjects newly initiated | |
| ARISTADA® | Subjects newly initiated | |
| INVEGA SUSTENNA® | Subjects newly initiated | |
| RISPERDAL CONSTA® | Subjects newly initiated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schizophrenia disease history
Including time (years) since diagnosis as assessed from clinical history
Measured: Baseline
Number of comorbid conditions at baseline
Assessed from clinical history
Measured: Baseline
Changes in comorbid conditions
The percent of patients experiencing each comorbid condition will be assessed at follow-up visits
Measured: Up to 12 months
Number of LAI injections
Average number of injections during treatment period
Measured: Up to 12 months
Number of patients switching or discontinuing LAI treatment
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start28 Mar 2019
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alkermes Medical Director, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919994
- Sponsor's protocol ID
- ALKS 9072-A403N
- Status last verified
- Feb 2023
- First submitted
- 1 Apr 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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. Changes in Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics (LAIs), Including Telepsychiatry Use, During the COVID-19 Pandemic. Neuropsychiatr Dis Treat. 2023 Mar 17;19:623-634. doi: 10.2147/NDT.S394220. eCollection 2023.
PubMed 36959874
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OASIS: Observational Study of LAIs In Schizophrenia
- ClinicalTrials.gov ID
- NCT03919994
- Acronym / sponsor ID
- ALKS 9072-A403N
- Conditions
- Schizophrenia
- Keywords
- Alkermes, Schizophrenia, ARISTADA, Abilify Maintena, Invega Sustenna, Risperdal Consta, Cohort Study, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABILIFY MAINTENA® | – | –Subjects newly initiated |
| ARISTADA® | – | –Subjects newly initiated |
| INVEGA SUSTENNA® | – | –Subjects newly initiated |
| RISPERDAL CONSTA® | – | –Subjects newly initiated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia who are newly initiating LAI treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 36959874Haider 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. Changes in Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics (LAIs), Including Telepsychiatry Use, During the COVID-19 Pandemic. Neuropsychiatr Dis Treat. 2023 Mar 17;19:623-634. doi: 10.2147/NDT.S394220. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alkermes Medical Director study director
Alkermes, Inc.
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Alkermes, Inc. at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schizophrenia disease history (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.