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
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Any FDA approved antipsychotic agent; aripiprazole long acting injectable formulation
Intervention type(s): Drug; Drug
Intervention description(s): Investigators are free to choose the most appropriate treatment for their clients
Intervention MeSH terms: Aripiprazole; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: First episode or recent onset