Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Antipsychotic; Drug: Antidepressant; Drug: Benzodiazepine; Drug: Mood stabilizer

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.

• Study Type: Observational
• Enrollment (Actual): 81921

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• The data source will be 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.

  • Schizophrenia will be defined as ≥2 outpatient claims or ≥1 inpatient claim for schizophrenia [ICD-9-CM: 295] during 365 days of consecutive Medicaid enrollment immediately prior to the index date. Stable antipsychotic monotherapy will be defined by filled prescriptions for only one second-generation antipsychotic, and no other psychotropics, for ≥ 90 days immediately preceding the start of the index medication (t0). After the ≥90 days of stable treatment with a single second-generation antipsychotic, study patients will have had a change in therapy defined as (1) addition of a second antipsychotic or (2) addition of a different psychotropic drug class (antidepressant, mood stabilizer, or benzodiazepine). To ensure the patients are in active treatment there must be an active supply of antipsychotic medication on t0.

Exclusion Criteria:

• Medicare recipients
• Patients receiving clozapine

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Antipsychotic; Individuals initiating treatment with an antipsychotic medication	Drug: Antipsychotic; New initiation of any antipsychotic medication
Antidepressant; Individuals initiating treatment with an antidepressant medication	Drug: Antidepressant; New initiation of any antidepressant medications
Benzodiazepine; Individuals initiating treatment with a benzodiazepine	Drug: Benzodiazepine; New initiation of any benzodiazepine
Mood stabilizer; Individuals initiating treatment with a mood stabilizer	Drug: Mood stabilizer; New initiation of lithium or any mood stabilizing anti-epileptic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychiatric Hospitalization	Number of participants hospitalized for a mental health reason	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Visit for Mental Health Reason	Number of Participants with an Emergency Department visit for mental health reason	One year
Death	Participants who died	One year

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: Patient-Centered Outcomes Research Institute; Rutgers University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimated): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antipsychotic Agents
• Other Study ID Numbers: 7226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO