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

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360319
• Other study ID #: COL.AOM.2013.005
• Status: Completed
• Phase: Phase 4
• Start date: December 11, 2014
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2020
• Source: Vanguard Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Any FDA approved antipsychotic agent
Investigators are free to choose the most appropriate treatment for their clients
• aripiprazole long acting injectable formulation

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Spindletop Center	Beaumont	Texas
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Central Community Health Board of Hamilton Co.	Cincinnati	Ohio
United States	Carolina Behavioral Care	Durham	North Carolina
United States	Early Treatment and Cognitive Health	East Lansing	Michigan
United States	PeaceHealth Medical Group	Eugene	Oregon
United States	Corrigan Mental Health Center	Fall River	Massachusetts
United States	Henderson Behavioral Health	Fort Lauderdale	Florida
United States	Meridian Behavioral Healthcare	Gainesville	Florida
United States	San Fernando Mental Health Center	Granada Hills	California
United States	Cherry Street Health Services	Grand Rapids	Michigan
United States	Chestnut Health Systems	Granite City	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Carey Counseling Center	Huntingdon	Tennessee
United States	University of Iowa Psychiatry Research	Iowa City	Iowa
United States	U. of Florida College of Medicine	Jacksonville	Florida
United States	WMU School of Medicine	Kalamazoo	Michigan
United States	LifeStream Behavioral Center	Leesburg	Florida
United States	MHC Community Healthcore	Longview	Texas
United States	The Mental Health Center of Greater Manchester	Manchester	New Hampshire
United States	Community Mental Health for Central Michigan	Mount Pleasant	Michigan
United States	Muskegon County Community Mental Health	Muskegon	Michigan
United States	Healthy Perspectives	Nashua	New Hampshire
United States	Creighton University	Omaha	Nebraska
United States	Stanford School of Medicine	Palo Alto	California
United States	New Bridge Medical Center	Paramus	New Jersey
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Saint Louis University CRU	Saint Louis	Missouri
United States	Suncoast Center	Saint Petersburg	Florida
United States	Psychiatric & Behavioral Solutions	Salt Lake City	Utah
United States	The Center for Health Care Services	San Antonio	Texas
United States	Apalachee Center, Inc.	Tallahassee	Florida
United States	La Frontera	Tucson	Arizona
United States	Jerome Golden Center for Behavioral Health	West Palm Beach	Florida
United States	The Counseling Center of Wayne and Holmes Counties	Wooster	Ohio
United States	U. Mass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Vanguard Research Group	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Hospitalization	Assessments are done using best available data and patient interviews	Hospitalizations assessed every 2 months from baseline to Month 24
Secondary	Total Number of Psychiatric Hospitalizations Per Treatment Arm	Assessments are completed using best available data and patient interviews	Measured every 2 months from baseline to month 24
Secondary	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.	Measured at Month 12 and Month 24
Secondary	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	Measured at Month 12 and Month 24
Secondary	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.	Measured at Month 12 and Month 24