Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia

Schizophrenia Clinical Trial

Official title:

Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775864
• Other study ID #: 7226
• Status: Completed
• Start date: July 2015
• Est. completion date: June 2018

Study information

• Verified date: April 2024
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81921
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Antipsychotic
New initiation of any antipsychotic medication
• Antidepressant
New initiation of any antidepressant medications
• Benzodiazepine
New initiation of any benzodiazepine
• Mood stabilizer
New initiation of lithium or any mood stabilizing anti-epileptic drug

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Patient-Centered Outcomes Research Institute, Rutgers University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychiatric Hospitalization	Number of participants hospitalized for a mental health reason	One year
Secondary	Emergency Department Visit for Mental Health Reason	Number of Participants with an Emergency Department visit for mental health reason	One year
Secondary	Death	Participants who died	One year