Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/15/2017 |
| Start Date: | September 2016 |
| End Date: | June 2019 |
The objective of this retrospective observational study is to compare commonly prescribed
bipolar disorder medications for their impact on: (1) all-cause mortality; (2)
hospitalization; (3) mood episodes; (4) suicide attempts and self-harm; and (5) risk of
drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. In
addition, the investigators will examine heterogeneity of treatment effect by co-morbidity
within pediatric, adult, and elderly sub-populations. Patient focus groups are convened to
elicit additional questions and provide feedback on results.
bipolar disorder medications for their impact on: (1) all-cause mortality; (2)
hospitalization; (3) mood episodes; (4) suicide attempts and self-harm; and (5) risk of
drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. In
addition, the investigators will examine heterogeneity of treatment effect by co-morbidity
within pediatric, adult, and elderly sub-populations. Patient focus groups are convened to
elicit additional questions and provide feedback on results.
Funded by PCORI, the objective of this retrospective observational study is to perform
several safety and effectiveness comparisons on commonly prescribed bipolar disorder
medications, engaging patient focus groups in generating additional questions and
interpreting results.
The study will be a retrospective cohort study conducted with administrative claims data from
the Truven MarketScan Commerical Claims and Encounters and Medicare database from 2010-2016.
The database contains approximately 100 million patients within the US population in every
state and nearly every county in the nation, across all ages, ethnicities and socioeconomic
categories, including privately insured, and Medicare patients. The study will focus on
approximately 1.3 million patients with two or more diagnoses of bipolar disorder in the
claims records according to ICD-9 and/or ICD-10 coding.
The treatments that will be compared are lithium carbonate; first generation antipsychotics:
haloperidol and perphenazine; second generation antipsychotics: clozapine, risperidone,
olanzapine, aripiprazole, quetiapine, ziprasidone, asenapine, lurasidone, and paliperidone;
mood stabilizing anticonvulsants: valproate, lamotrigine, carbamazepine, and oxcarbazepine;
antidepressants: mirtazapine, bupropion, desvenlafaxine, duloxetine, venlafaxine, citalopram,
escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone, and doxepin.
The investigators will perform cross-sectional and survival based analysis using regression,
propensity scoring, and local control to perform bias-corrected comparisons of the above
treatments for for their impact on: (1) all-cause mortality; (2) risk of hospitalization; (3)
frequency of manic and depressive mood episodes; (4) risk of suicide attempts and self-harm;
and (5) risk of drug-induced adverse effects such as kidney disease/failure and metabolic
syndrome. In addition, the investigators will examine heterogeneity of treatment effect by
co-morbidity within pediatric, adult, and elderly sub-populations.
several safety and effectiveness comparisons on commonly prescribed bipolar disorder
medications, engaging patient focus groups in generating additional questions and
interpreting results.
The study will be a retrospective cohort study conducted with administrative claims data from
the Truven MarketScan Commerical Claims and Encounters and Medicare database from 2010-2016.
The database contains approximately 100 million patients within the US population in every
state and nearly every county in the nation, across all ages, ethnicities and socioeconomic
categories, including privately insured, and Medicare patients. The study will focus on
approximately 1.3 million patients with two or more diagnoses of bipolar disorder in the
claims records according to ICD-9 and/or ICD-10 coding.
The treatments that will be compared are lithium carbonate; first generation antipsychotics:
haloperidol and perphenazine; second generation antipsychotics: clozapine, risperidone,
olanzapine, aripiprazole, quetiapine, ziprasidone, asenapine, lurasidone, and paliperidone;
mood stabilizing anticonvulsants: valproate, lamotrigine, carbamazepine, and oxcarbazepine;
antidepressants: mirtazapine, bupropion, desvenlafaxine, duloxetine, venlafaxine, citalopram,
escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone, and doxepin.
The investigators will perform cross-sectional and survival based analysis using regression,
propensity scoring, and local control to perform bias-corrected comparisons of the above
treatments for for their impact on: (1) all-cause mortality; (2) risk of hospitalization; (3)
frequency of manic and depressive mood episodes; (4) risk of suicide attempts and self-harm;
and (5) risk of drug-induced adverse effects such as kidney disease/failure and metabolic
syndrome. In addition, the investigators will examine heterogeneity of treatment effect by
co-morbidity within pediatric, adult, and elderly sub-populations.
Inclusion Criteria:
- Two or more instances of bipolar disorder diagnoses within administrative claims
records
Exclusion Criteria:
- Patients with less than 1 year of history in the database
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