Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

University of New Mexico (UNM)

Status

Terminated

Conditions

Bipolar Disorder

Treatments

Drug: Paliperidone

Drug: Aripiprazole

Drug: Escitalopram

Drug: Doxepin

Drug: Mirtazapine

Drug: Lamotrigine

Drug: Olanzapine

Drug: Ziprasidone

Drug: Quetiapine

Drug: Oxcarbazepine

Drug: Desvenlafaxine

Drug: Risperidone

Drug: Haloperidol

Drug: Paroxetine

Drug: Vilazodone

Drug: Lurasidone

Drug: Fluoxetine

Drug: Valproic Acid

Drug: Duloxetine

Drug: Clozapine

Drug: Sertraline

Drug: Lithium Carbonate

Drug: Fluvoxamine

Drug: Asenapine

Drug: Carbamazepine

Drug: Perphenazine

Drug: Venlafaxine

Drug: Bupropion

Drug: Fluoxetine / Olanzapine

Drug: Citalopram

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02893371

CER-1507-31607 (Other Grant/Funding Number)

16-243

Details and patient eligibility

About

The objective of this retrospective observational study is to compare commonly prescribed bipolar disorder medications for their impact on: (1) hospitalization; (2) suicide attempts and self-harm; and (3) risk of drug-induced adverse effects such as kidney disease and diabetes mellitus. 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.

Full 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 140 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 one 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) hospitalization; (2) suicide attempts and self-harm; and (3) risk of drug-induced adverse effects such as kidney disease and diabetes mellitus. In addition, the investigators will examine heterogeneity of treatment effect by co-morbidity within pediatric, adult, and elderly sub-populations.

Enrollment

1,037,352 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria