Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      The study is a retrospective cohort study of adults with schizophrenia that will compare
      outcomes of new users of alternative psychotropic medication strategies using 10 years of
      Medicaid data. The primary comparative effectiveness analyses will focus on subgroups of
      patients with schizophrenia facing common clinical situations.
    

Detailed description: 
      This retrospective cohort study will use data from national (45-state) Medicaid Analytic
      Extracts data (2001-2010). The cohort will consist of adults who are 18 to 64 years old and
      diagnosed with schizophrenia who initiate a new psychotropic medication after a period of
      stable antipsychotic treatment.

      The eligibility criteria select a cohort of individuals diagnosed with schizophrenia, have
      received antipsychotic monotherapy prior to the index date, and are still experiencing
      problems for which a new psychotropic medication strategy was initiated. A 1-year period of
      eligibility prior to follow-up initiation ensures sufficient time to collect service use
      related covariates to characterize cohort members.

      Five clinical subgroups will be defined based on the presence of psychiatric diagnoses during
      the 30 days prior to and inclusive of the treatment change under study (index date) and who
      have this same diagnostic code from more than one provider to increase the validity of the
      diagnostic groups. The subgroups will be defined by codes to capture 1) uncomplicated
      schizophrenia; 2) schizoaffective disorder; 3) depression; 4) mania; and 5) anxiety. These
      subgroups are defined to reflect the reason for the change in treatment.

      Pharmacological treatment options for patients with schizophrenia who are nonresponsive to
      antipsychotic monotherapy will include (1) initiation of a second antipsychotic, (2)
      initiation of an antidepressant, (3) initiation of a mood stabilizer and (4) initiation of a
      benzodiazepine.

      The primary effectiveness outcome will be time to psychiatric hospitalization. Secondary
      measures include time to index treatment discontinuation, time to introduction of another
      psychotropic medication, psychiatric emergency department visits, all-cause hospitalization,
      and death.
    

Intervention name(s): Antipsychotic; Antidepressant; Benzodiazepine; Mood stabilizer
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): New initiation of any antipsychotic medication; New initiation of any antidepressant medications; New initiation of any benzodiazepine; New initiation of lithium or any mood stabilizing anti-epileptic drug
Intervention MeSH terms: Antipsychotic Agents; Antidepressive Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults diagnosed with schizophrenia who are taking only a single antipsychotic medication
        who initiate treatment with an additional psychotropic medication.