Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
- Conditions
- Schizophrenia
- Interventions
- Drug: Any FDA approved antipsychotic agent
- Registration Number
- NCT02360319
- Lead Sponsor
- Vanguard Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 489
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aripiprazole Once Monthly aripiprazole long acting injectable formulation Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years Clinician's Choice Any FDA approved antipsychotic agent 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
- Primary Outcome Measures
Name Time Method Time to First Hospitalization Hospitalizations assessed every 2 months from baseline to Month 24 Assessments are done using best available data and patient interviews
- Secondary Outcome Measures
Name Time Method Total Number of Psychiatric Hospitalizations Per Treatment Arm Measured every 2 months from baseline to month 24 Assessments are completed using best available data and patient interviews
Brief Psychotic Rating Scale (BPRS) Total Score Measured at Month 12 and Month 24 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 Measured at Month 12 and Month 24 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 Measured at Month 12 and Month 24 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.
Trial Locations
- Locations (39)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
LifeStream Behavioral Center
🇺🇸Leesburg, Florida, United States
Cherry Street Health Services
🇺🇸Grand Rapids, Michigan, United States
New Bridge Medical Center
🇺🇸Paramus, New Jersey, United States
Community Mental Health for Central Michigan
🇺🇸Mount Pleasant, Michigan, United States
Muskegon County Community Mental Health
🇺🇸Muskegon, Michigan, United States
PeaceHealth Medical Group
🇺🇸Eugene, Oregon, United States
U. Mass Medical School
🇺🇸Worcester, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
San Fernando Mental Health Center
🇺🇸Granada Hills, California, United States
Stanford School of Medicine
🇺🇸Palo Alto, California, United States
Henderson Behavioral Health
🇺🇸Fort Lauderdale, Florida, United States
Suncoast Center
🇺🇸Saint Petersburg, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Iowa Psychiatry Research
🇺🇸Iowa City, Iowa, United States
Chestnut Health Systems
🇺🇸Granite City, Illinois, United States
Central Community Health Board of Hamilton Co.
🇺🇸Cincinnati, Ohio, United States
Psychiatric & Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
The Center for Health Care Services
🇺🇸San Antonio, Texas, United States
Early Treatment and Cognitive Health
🇺🇸East Lansing, Michigan, United States
La Frontera
🇺🇸Tucson, Arizona, United States
U. of Florida College of Medicine
🇺🇸Jacksonville, Florida, United States
Apalachee Center, Inc.
🇺🇸Tallahassee, Florida, United States
WMU School of Medicine
🇺🇸Kalamazoo, Michigan, United States
Meridian Behavioral Healthcare
🇺🇸Gainesville, Florida, United States
Carey Counseling Center
🇺🇸Huntingdon, Tennessee, United States
Jerome Golden Center for Behavioral Health
🇺🇸West Palm Beach, Florida, United States
Corrigan Mental Health Center
🇺🇸Fall River, Massachusetts, United States
Saint Louis University CRU
🇺🇸Saint Louis, Missouri, United States
The Mental Health Center of Greater Manchester
🇺🇸Manchester, New Hampshire, United States
Carolina Behavioral Care
🇺🇸Durham, North Carolina, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
The Counseling Center of Wayne and Holmes Counties
🇺🇸Wooster, Ohio, United States
MHC Community Healthcore
🇺🇸Longview, Texas, United States
Spindletop Center
🇺🇸Beaumont, Texas, United States
Healthy Perspectives
🇺🇸Nashua, New Hampshire, United States