Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
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|ClinicalTrials.gov Identifier: NCT02775864|
Recruitment Status : Completed
First Posted : May 18, 2016
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment|
|Schizophrenia Schizoaffective Disorder||Drug: Antipsychotic Drug: Antidepressant Drug: Benzodiazepine Drug: Mood stabilizer|
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|
|Actual Enrollment :||81921 participants|
|Official Title:||Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||June 2018|
Individuals initiating treatment with an antipsychotic medication
New initiation of any antipsychotic medication
Individuals initiating treatment with an antidepressant medication
New initiation of any antidepressant medications
Individuals initiating treatment with a benzodiazepine
New initiation of any benzodiazepine
Individuals initiating treatment with a mood stabilizer
Drug: Mood stabilizer
New initiation of lithium or any mood stabilizing anti-epileptic drug
- Psychiatric Hospitalization [ Time Frame: One year ]Number of participants hospitalized for a mental health reason
- Emergency Department Visit for Mental Health Reason [ Time Frame: One year ]Number of Participants with an Emergency Department visit for mental health reason
- Death [ Time Frame: One year ]Participants who died