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Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics (PRELAPSE)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Any FDA approved antipsychotic agent
aripiprazole long acting injectable formulation
Sponsored by
Vanguard Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring First episode or recent onset

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Are able to provide written informed consent Have a confirmed diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM) 5 criteria using the SCID (Structured Clinical Interview for DSM disorders) Are between the ages of 18 and 35, inclusive Have the following history with antipsychotic medications

  1. First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis
  2. EP subjects: between 1 year and 5 years of lifetime exposure to antipsychotic medication or subjects with < 1 year of lifetime antipsychotic medication and more than one episode of psychosis.

For LAI subjects: Must be willing to accept an injectable form of treatment

Exclusion Criteria:

Have a current primary DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, and amnestic or other cognitive disorders.

For LAI sites only - have a known allergy or intolerance to aripiprazole, or a past negative response to aripiprazole that is not explained by nonadherence Be pregnant or lactating Have any unstable medical condition that, in the opinion of the investigator, would be detrimental to the subject or would confound the results of the study Subjects in the MRI subset only- presence of any metal implants, pacemakers, irremovable prosthetic devices, or other devices or situations that may preclude imaging

Sites / Locations

  • La Frontera
  • San Fernando Mental Health Center
  • Stanford School of Medicine
  • Henderson Behavioral Health
  • Meridian Behavioral Healthcare
  • U. of Florida College of Medicine
  • LifeStream Behavioral Center
  • Suncoast Center
  • Apalachee Center, Inc.
  • Jerome Golden Center for Behavioral Health
  • Grady Memorial Hospital
  • Augusta University
  • Northwestern University Feinberg School of Medicine
  • Chestnut Health Systems
  • University of Iowa Psychiatry Research
  • Corrigan Mental Health Center
  • U. Mass Medical School
  • University of Michigan
  • Early Treatment and Cognitive Health
  • Cherry Street Health Services
  • WMU School of Medicine
  • Community Mental Health for Central Michigan
  • Muskegon County Community Mental Health
  • Saint Louis University CRU
  • PsychCare Consultants Research
  • Creighton University
  • The Mental Health Center of Greater Manchester
  • Healthy Perspectives
  • New Bridge Medical Center
  • Carolina Behavioral Care
  • Central Community Health Board of Hamilton Co.
  • The Counseling Center of Wayne and Holmes Counties
  • PeaceHealth Medical Group
  • Carey Counseling Center
  • Spindletop Center
  • Baylor College of Medicine
  • MHC Community Healthcore
  • The Center for Health Care Services
  • Psychiatric & Behavioral Solutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clinician's Choice

Aripiprazole Once Monthly

Arm Description

Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years

Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years

Outcomes

Primary Outcome Measures

Time to First Hospitalization
Assessments are done using best available data and patient interviews

Secondary Outcome Measures

Total Number of Psychiatric Hospitalizations Per Treatment Arm
Assessments are completed using best available data and patient interviews
Brief Psychotic Rating Scale (BPRS) Total Score
The Brief Psychotic Rating Scale is an 18 item scale where each item is rated 1-7, the minimum total score is 18 and the maximum total score is 126. Higher scores indicate more severe symptoms.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a 12 item scale with a total score range of 0 to 321 with higher scores indicating better cognitive functioning
Quality of Life (QLS) Total Score
Quality of Life (QLS) is a 21 item scale where each item is rated from 0 to 7, the minimum score is 0 and the maximum score is 126 with higher scores indicating better overall functioning.

Full Information

First Posted
February 2, 2015
Last Updated
November 16, 2020
Sponsor
Vanguard Research Group
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02360319
Brief Title
Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
Acronym
PRELAPSE
Official Title
A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment With Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 11, 2014 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanguard Research Group
Collaborators
Otsuka America Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode (<1 year of anti-psychotic medication) or early phase (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable (LAI) antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites (not individual patients) will be randomly assigned to either medication prescribed by their treating physician (with no restrictions) or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.
Detailed Description
Approximately 40 U.S. sites will participate in the study in order to enroll approximately 500 patients over a year period. They will be recruited into two cohorts - the first episode cohort and the early phase (EP) cohort, with approximately 250 patients in each cohort. Enrollment of patients will be discontinued when the appropriate number for the target for each cohort is reached. After providing written informed consent, patients will be screened for general eligibility by the clinical team at the site. Basic demographic data will be collected to determine suitability for inclusion into the study. The site will complete an information interview comprising data regarding symptomology and history, but the diagnosis of schizophrenia will fall to a centralized, remote blinded rater to enable consistency for eligibility. Prescribers at sites in the clinician's choice arm can treat the patients in the manner most appropriate for that individual. Prescribers at sites in the Aripiprazole Once Monthly arm monthly will prescribe and administer the medication according to recommendations contained in the product labeling. For a period of 2 years all subjects will receive bimonthly calls inquiring about visits to emergency rooms and hospitalization. At 4 month intervals information on use of services, insurance status, work, school attendance, and other service use outcomes will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
First episode or recent onset

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
489 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician's Choice
Arm Type
Active Comparator
Arm Description
Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years
Arm Title
Aripiprazole Once Monthly
Arm Type
Experimental
Arm Description
Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years
Intervention Type
Drug
Intervention Name(s)
Any FDA approved antipsychotic agent
Intervention Description
Investigators are free to choose the most appropriate treatment for their clients
Intervention Type
Drug
Intervention Name(s)
aripiprazole long acting injectable formulation
Primary Outcome Measure Information:
Title
Time to First Hospitalization
Description
Assessments are done using best available data and patient interviews
Time Frame
Hospitalizations assessed every 2 months from baseline to Month 24
Secondary Outcome Measure Information:
Title
Total Number of Psychiatric Hospitalizations Per Treatment Arm
Description
Assessments are completed using best available data and patient interviews
Time Frame
Measured every 2 months from baseline to month 24
Title
Brief Psychotic Rating Scale (BPRS) Total Score
Description
The Brief Psychotic Rating Scale is an 18 item scale where each item is rated 1-7, the minimum total score is 18 and the maximum total score is 126. Higher scores indicate more severe symptoms.
Time Frame
Measured at Month 12 and Month 24
Title
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores
Description
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a 12 item scale with a total score range of 0 to 321 with higher scores indicating better cognitive functioning
Time Frame
Measured at Month 12 and Month 24
Title
Quality of Life (QLS) Total Score
Description
Quality of Life (QLS) is a 21 item scale where each item is rated from 0 to 7, the minimum score is 0 and the maximum score is 126 with higher scores indicating better overall functioning.
Time Frame
Measured at Month 12 and Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are able to provide written informed consent Have a confirmed diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM) 5 criteria using the SCID (Structured Clinical Interview for DSM disorders) Are between the ages of 18 and 35, inclusive Have the following history with antipsychotic medications First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis EP subjects: between 1 year and 5 years of lifetime exposure to antipsychotic medication or subjects with < 1 year of lifetime antipsychotic medication and more than one episode of psychosis. For LAI subjects: Must be willing to accept an injectable form of treatment Exclusion Criteria: Have a current primary DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, and amnestic or other cognitive disorders. For LAI sites only - have a known allergy or intolerance to aripiprazole, or a past negative response to aripiprazole that is not explained by nonadherence Be pregnant or lactating Have any unstable medical condition that, in the opinion of the investigator, would be detrimental to the subject or would confound the results of the study Subjects in the MRI subset only- presence of any metal implants, pacemakers, irremovable prosthetic devices, or other devices or situations that may preclude imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Kane, M.D.
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Frontera
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
Facility Name
San Fernando Mental Health Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Stanford School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Henderson Behavioral Health
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Meridian Behavioral Healthcare
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32614
Country
United States
Facility Name
U. of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
LifeStream Behavioral Center
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34749
Country
United States
Facility Name
Suncoast Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Apalachee Center, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Jerome Golden Center for Behavioral Health
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Chestnut Health Systems
City
Granite City
State/Province
Illinois
ZIP/Postal Code
62040
Country
United States
Facility Name
University of Iowa Psychiatry Research
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Corrigan Mental Health Center
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
U. Mass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Early Treatment and Cognitive Health
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Cherry Street Health Services
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
WMU School of Medicine
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Community Mental Health for Central Michigan
City
Mount Pleasant
State/Province
Michigan
ZIP/Postal Code
48858
Country
United States
Facility Name
Muskegon County Community Mental Health
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49433
Country
United States
Facility Name
Saint Louis University CRU
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
The Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03101
Country
United States
Facility Name
Healthy Perspectives
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
New Bridge Medical Center
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Carolina Behavioral Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Central Community Health Board of Hamilton Co.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Counseling Center of Wayne and Holmes Counties
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
PeaceHealth Medical Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Carey Counseling Center
City
Huntingdon
State/Province
Tennessee
ZIP/Postal Code
38344
Country
United States
Facility Name
Spindletop Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
MHC Community Healthcore
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
The Center for Health Care Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Psychiatric & Behavioral Solutions
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32667636
Citation
Kane JM, Schooler NR, Marcy P, Correll CU, Achtyes ED, Gibbons RD, Robinson DG. Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Dec 1;77(12):1217-1224. doi: 10.1001/jamapsychiatry.2020.2076. Erratum In: JAMA Psychiatry. 2020 Dec 1;77(12):1310.
Results Reference
derived
PubMed Identifier
31050233
Citation
Kane JM, Schooler NR, Marcy P, Achtyes ED, Correll CU, Robinson DG. Patients With Early-Phase Schizophrenia Will Accept Treatment With Sustained-Release Medication (Long-Acting Injectable Antipsychotics): Results From the Recruitment Phase of the PRELAPSE Trial. J Clin Psychiatry. 2019 Apr 23;80(3):18m12546. doi: 10.4088/JCP.18m12546.
Results Reference
derived

Learn more about this trial

Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics

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