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)
Schizophrenia
About this trial
This is an interventional health services research trial for Schizophrenia focused on measuring First episode or recent onset
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
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
Active Comparator
Experimental
Clinician's Choice
Aripiprazole Once Monthly
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