N/A
Completed N=81,921
Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
Source: ClinicalTrials.gov NCT02775864 ↗Enrolled (actual)
81,921
Serious AEs
0.3%
Results posted
Jun 2019
Primary outcomePrimary: Psychiatric Hospitalization — 4965; 5247; 2385; 3093 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychiatric Hospitalization |
4965; 5247; 2385; 3093 | — |
| SECONDARY Emergency Department Visit for Mental Health Reason |
5505; 6508; 2930; 3429 | — |
| SECONDARY Death |
259; 327; 204; 161 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02775864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.