Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Any FDA approved antipsychotic agent; aripiprazole long acting injectable formulation
Intervention description: Investigators are free to choose the most appropriate treatment for their clients
Intervention MeSH terms: Aripiprazole; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 489.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: First episode or recent onset

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.
    

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