Schizophrenia, Schizoaffective Disorder
Conditions
Brief 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.
Interventions
DRUGAntipsychotic
New initiation of any antipsychotic medication
DRUGAntidepressant
New initiation of any antidepressant medications
DRUGBenzodiazepine
New initiation of any benzodiazepine
DRUGMood stabilizer
New initiation of lithium or any mood stabilizing anti-epileptic drug
Sponsors
Rutgers University
Patient-Centered Outcomes Research Institute
New York State Psychiatric Institute
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric Hospitalization | One year | Number of participants hospitalized for a mental health reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Visit for Mental Health Reason | One year | Number of Participants with an Emergency Department visit for mental health reason |
| Death | One year | Participants who died |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antipsychotic Individuals initiating treatment with an antipsychotic medication
Antipsychotic: New initiation of any antipsychotic medication | 26,014 |
| Antidepressant Individuals initiating treatment with an antidepressant medication
Antidepressant: New initiation of any antidepressant medications | 31,117 |
| Benzodiazepine Individuals initiating treatment with a benzodiazepine
Benzodiazepine: New initiation of any benzodiazepine | 11,941 |
| Mood Stabilizer Individuals initiating treatment with a mood stabilizer
Mood stabilizer: New initiation of lithium or any mood stabilizing anti-epileptic drug | 12,849 |
| Total | 81,921 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Data ended end of 2010 | 1,764 | 2,880 | 1,140 | 1,194 |
| Overall Study | Medicaid eligibility discontinued | 1,478 | 2,019 | 720 | 890 |
Baseline characteristics
| Characteristic | Total | Mood Stabilizer | Benzodiazepine | Antidepressant | Antipsychotic |
|---|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 12.5 | 40.3 years STANDARD_DEVIATION 12.5 | 40.5 years STANDARD_DEVIATION 12.5 | 40.5 years STANDARD_DEVIATION 12.4 | 40.5 years STANDARD_DEVIATION 12.5 |
| Race/Ethnicity, Customized Asian | 1595 Participants | 237 Participants | 252 Participants | 461 Participants | 645 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 32026 Participants | 5465 Participants | 3731 Participants | 12459 Participants | 10371 Participants |
| Race/Ethnicity, Customized Hawaiian or Pacific Islander | 2152 Participants | 287 Participants | 339 Participants | 744 Participants | 782 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8135 Participants | 1263 Participants | 1159 Participants | 3196 Participants | 2517 Participants |
| Race/Ethnicity, Customized More than one race | 163 Participants | 26 Participants | 19 Participants | 67 Participants | 51 Participants |
| Race/Ethnicity, Customized Native American or Alaskan Native | 736 Participants | 87 Participants | 104 Participants | 305 Participants | 240 Participants |
| Race/Ethnicity, Customized Unknown | 7925 Participants | 1223 Participants | 1152 Participants | 2787 Participants | 2763 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 30090 Participants | 4261 Participants | 5186 Participants | 10998 Participants | 9645 Participants |
| Sex: Female, Male Female | 37725 Participants | 5975 Participants | 5553 Participants | 14283 Participants | 11914 Participants |
| Sex: Female, Male Male | 44196 Participants | 6874 Participants | 6388 Participants | 16834 Participants | 14100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 259 / 26,014 | 327 / 31,117 | 204 / 11,941 | 161 / 12,849 |
| other Total, other adverse events | 967 / 21,738 | 1,004 / 26,062 | 424 / 9,764 | 423 / 10,564 |
| serious Total, serious adverse events | 67 / 26,014 | 102 / 31,117 | 43 / 11,941 | 41 / 12,849 |
Outcome results
Primary
Psychiatric Hospitalization
Number of participants hospitalized for a mental health reason
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antipsychotic | Psychiatric Hospitalization | 4965 Participants |
| Antidepressant | Psychiatric Hospitalization | 5247 Participants |
| Benzodiazepine | Psychiatric Hospitalization | 2385 Participants |
| Mood Stabilizer | Psychiatric Hospitalization | 3093 Participants |
Secondary
Death
Participants who died
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antipsychotic | Death | 259 Participants |
| Antidepressant | Death | 327 Participants |
| Benzodiazepine | Death | 204 Participants |
| Mood Stabilizer | Death | 161 Participants |
Secondary
Emergency Department Visit for Mental Health Reason
Number of Participants with an Emergency Department visit for mental health reason
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antipsychotic | Emergency Department Visit for Mental Health Reason | 5505 Participants |
| Antidepressant | Emergency Department Visit for Mental Health Reason | 6508 Participants |
| Benzodiazepine | Emergency Department Visit for Mental Health Reason | 2930 Participants |
| Mood Stabilizer | Emergency Department Visit for Mental Health Reason | 3429 Participants |