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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03919994

Collaborator

(none)

338

Enrollment

Locations

44.2

Anticipated Duration (Months)

5.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Schizophrenia

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

Actual Enrollment :

338 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

OASIS: Observational Study of LAIs In Schizophrenia

Actual Study Start Date :

Mar 28, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
ABILIFY MAINTENA® Subjects newly initiated
ARISTADA® Subjects newly initiated
INVEGA SUSTENNA® Subjects newly initiated
RISPERDAL CONSTA® Subjects newly initiated

Outcome Measures

Primary Outcome Measures

Schizophrenia disease history [Baseline]
Including time (years) since diagnosis as assessed from clinical history
Number of comorbid conditions at baseline [Baseline]
Assessed from clinical history
Changes in comorbid conditions [Up to 12 months]
The percent of patients experiencing each comorbid condition will be assessed at follow-up visits
Number of LAI injections [Up to 12 months]
Average number of injections during treatment period
Number of patients switching or discontinuing LAI treatment [Up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Alkermes Investigational Site	Tucson	Arizona	United States	85719
2	Alkermes Investigational Site	Costa Mesa	California	United States	92626
3	Alkermes Investigational Site	El Cajon	California	United States	92021
4	Alkermes Investigational Site	Granada Hills	California	United States	91334
5	Alkermes Investigational Site	Oceanside	California	United States	92054
6	Alkermes Investigational Site	Panorama City	California	United States	91402
7	Alkermes Investigational Site	San Bernardino	California	United States	92404
8	Alkermes Investigational Site	Dayville	Connecticut	United States	06241
9	Alkermes Investigational Site	Hialeah	Florida	United States	33012
10	Alkermes Investigational Site	Hialeah	Florida	United States	33016
11	Alkermes Investigational Site	Lauderdale Lakes	Florida	United States	33319
12	Alkermes Investigational Site	Miami Gardens	Florida	United States	33014
13	Alkermes Investigational Site	Miami	Florida	United States	33136
14	Alkermes Investigational Site	Orlando	Florida	United States	32803
15	Alkermes Investigational Site	Panama City	Florida	United States	32405
16	Alkermes Investigational Site	Tallahassee	Florida	United States	32308
17	Alkermes Investigational Site	Augusta	Georgia	United States	30912
18	Alkermes Investigational Site	Lawrenceville	Georgia	United States	30046
19	Alkermes Investigational Site	Honolulu	Hawaii	United States	96817
20	Alkermes Investigational Site	Honolulu	Hawaii	United States	96826
21	Alkermes Investigational Site	Schaumburg	Illinois	United States	60194
22	Alkermes Investigational Site	Springfield	Illinois	United States	62702
23	Alkermes Investigational Site	Indianapolis	Indiana	United States	46202
24	Alkermes Investigational Site	Bel Air	Maryland	United States	21015
25	Alkermes Investigational Site	Boston	Massachusetts	United States	02114
26	Alkermes Investigational Site	Grand Rapids	Michigan	United States	49503
27	Alkermes Investigational Site	Kalamazoo	Michigan	United States	49008
28	Alkermes Investigational Site	Kansas City	Missouri	United States	64108
29	Alkermes Investigational Site	Raymore	Missouri	United States	64083
30	Alkermes Investigational Site	Saint Louis	Missouri	United States	63118
31	Alkermes Investigational Site	Saint Louis	Missouri	United States	63128
32	Alkermes Investigational Site	Saint Louis	Missouri	United States	63141
33	Alkermes Investigational Site	Lincoln	Nebraska	United States	68526
34	Alkermes Investigational Site	Manchester	New Hampshire	United States	03101
35	Alkermes Investigational Site	Buffalo	New York	United States	14215
36	Alkermes Investigational Site	Glen Oaks	New York	United States	11004
37	Alkermes Investigational Site	Jamaica	New York	United States	11418
38	Alkermes Investigational Site	New York	New York	United States	10032
39	Alkermes Investigational Site	Poughkeepsie	New York	United States	12603
40	Alkermes Investigational Site	Beachwood	Ohio	United States	44122
41	Alkermes Investigational Site	Fairlawn	Ohio	United States	44333
42	Alkermes Investigational Site	Westlake	Ohio	United States	44145
43	Alkermes Investigational Site	Wooster	Ohio	United States	44691
44	Alkermes Investigational Site	Durant	Oklahoma	United States	74701
45	Alkermes Investigational Site	Tulsa	Oklahoma	United States	74114
46	Alkermes Investigational Site	Tulsa	Oklahoma	United States	74136
47	Alkermes Investigational Site	Eugene	Oregon	United States	97401
48	Alkermes Investigational Site	Wyomissing	Pennsylvania	United States	19610
49	Alkermes Investigational Site	Sioux Falls	South Dakota	United States	57104
50	Alkermes Investigational Site	Franklin	Tennessee	United States	37067
51	Alkermes Investigational Site	Austin	Texas	United States	78746
52	Alkermes Investigational Site	Fort Worth	Texas	United States	76104
53	Alkermes Investigational Site	Houston	Texas	United States	77074
54	Alkermes Investigational Site	Richmond	Texas	United States	77407
55	Alkermes Investigational Site	San Antonio	Texas	United States	78229
56	Alkermes Investigational Site	Wichita Falls	Texas	United States	76306
57	Alkermes Investigational Site	Salt Lake City	Utah	United States	84105