Clinical trial NCT02360319: Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: First episode or recent onset
Lead sponsor: Vanguard Research Group
Sponsor class: OTHER
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2015-02-10
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

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

Primary outcomes:
measure: Time to First Hospitalization
timeFrame: Hospitalizations assessed every 2 months from baseline to Month 24
Secondary outcomes:
measure: Total Number of Psychiatric Hospitalizations Per Treatment Arm
timeFrame: Measured every 2 months from baseline to month 24
measure: Brief Psychotic Rating Scale (BPRS) Total Score
timeFrame: Measured at Month 12 and Month 24
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores
timeFrame: Measured at Month 12 and Month 24
measure: Quality of Life (QLS) Total Score
timeFrame: Measured at Month 12 and Month 24
Other outcomes:
Locations:
city: Tucson
country: United States
facility: La Frontera
state: Arizona
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
city: Palo Alto
country: United States
facility: Stanford School of Medicine
state: California
city: Fort Lauderdale
country: United States
facility: Henderson Behavioral Health
state: Florida
city: Gainesville
country: United States
facility: Meridian Behavioral Healthcare
state: Florida
city: Jacksonville
country: United States
facility: U. of Florida College of Medicine
state: Florida
city: Leesburg
country: United States
facility: LifeStream Behavioral Center
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Center
state: Florida
city: Tallahassee
country: United States
facility: Apalachee Center, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Jerome Golden Center for Behavioral Health
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Granite City
country: United States
facility: Chestnut Health Systems
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Psychiatry Research
state: Iowa
city: Fall River
country: United States
facility: Corrigan Mental Health Center
state: Massachusetts
city: Worcester
country: United States
facility: U. Mass Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Lansing
country: United States
facility: Early Treatment and Cognitive Health
state: Michigan
city: Grand Rapids
country: United States
facility: Cherry Street Health Services
state: Michigan
city: Kalamazoo
country: United States
facility: WMU School of Medicine
state: Michigan
city: Mount Pleasant
country: United States
facility: Community Mental Health for Central Michigan
state: Michigan
city: Muskegon
country: United States
facility: Muskegon County Community Mental Health
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University CRU
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
city: Nashua
country: United States
facility: Healthy Perspectives
state: New Hampshire
city: Paramus
country: United States
facility: New Bridge Medical Center
state: New Jersey
city: Durham
country: United States
facility: Carolina Behavioral Care
state: North Carolina
city: Cincinnati
country: United States
facility: Central Community Health Board of Hamilton Co.
state: Ohio
city: Wooster
country: United States
facility: The Counseling Center of Wayne and Holmes Counties
state: Ohio
city: Eugene
country: United States
facility: PeaceHealth Medical Group
state: Oregon
city: Huntingdon
country: United States
facility: Carey Counseling Center
state: Tennessee
city: Beaumont
country: United States
facility: Spindletop Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Longview
country: United States
facility: MHC Community Healthcore
state: Texas
city: San Antonio
country: United States
facility: The Center for Health Care Services
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric & Behavioral Solutions
state: Utah
Study officials:
affiliation: Northwell Health
name: John M Kane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.