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

Completed · Phase 4

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02360319

Run by

Vanguard Research Group

People needed

489

Starts

2014-12-11

Expected to finish

2019-03-31

Last updated by the study team

2020-12-02

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• La Frontera — Tucson, Arizona, 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
• Meridian Behavioral Healthcare — Gainesville, Florida, United States
• U. of Florida College of Medicine — Jacksonville, Florida, United States
• LifeStream Behavioral Center — Leesburg, Florida, United States
• Suncoast Center — St. Petersburg, Florida, United States
• Apalachee Center, Inc. — Tallahassee, Florida, United States
• Jerome Golden Center for Behavioral Health — West Palm Beach, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Chestnut Health Systems — Granite City, Illinois, United States
• University of Iowa Psychiatry Research — Iowa City, Iowa, United States
• Corrigan Mental Health Center — Fall River, Massachusetts, United States
• U. Mass Medical School — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Early Treatment and Cognitive Health — East Lansing, Michigan, United States
• Cherry Street Health Services — Grand Rapids, Michigan, United States
• WMU School of Medicine — Kalamazoo, Michigan, United States
• Community Mental Health for Central Michigan — Mount Pleasant, Michigan, United States
• Muskegon County Community Mental Health — Muskegon, Michigan, United States
• Saint Louis University CRU — St Louis, Missouri, United States
• PsychCare Consultants Research — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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