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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02893371
Study type Observational
Source University of New Mexico
Contact
Status Enrolling by invitation
Phase N/A
Start date September 2016
Completion date June 2019

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