NCT02893371

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,037,352 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lithium Carbonate	Exposure to all dosages and delivery forms.
DRUG	Lamotrigine	Exposure to all dosages and delivery forms.
DRUG	Valproic Acid	Exposure to all dosages and delivery forms.
DRUG	Oxcarbazepine	Exposure to all dosages and delivery forms.
DRUG	Carbamazepine	Exposure to all dosages and delivery forms.
DRUG	Ziprasidone	Exposure to all dosages and delivery forms.
DRUG	Risperidone	Exposure to all dosages and delivery forms.
DRUG	Quetiapine	Exposure to all dosages and delivery forms.
DRUG	Olanzapine	Exposure to all dosages and delivery forms.
DRUG	Aripiprazole	Exposure to all dosages and delivery forms.
DRUG	Fluoxetine / Olanzapine	Exposure to all dosages and delivery forms.
DRUG	Haloperidol	Exposure to all dosages and delivery forms.
DRUG	Perphenazine	Exposure to all dosages and delivery forms.
DRUG	Clozapine	Exposure to all dosages and delivery forms.
DRUG	Asenapine	Exposure to all dosages and delivery forms.
DRUG	Lurasidone	Exposure to all dosages and delivery forms.
DRUG	Paliperidone	Exposure to all dosages and delivery forms.
DRUG	Mirtazapine	Exposure to all dosages and delivery forms.
DRUG	Bupropion	Exposure to all dosages and delivery forms.
DRUG	Desvenlafaxine	Exposure to all dosages and delivery forms.
DRUG	Duloxetine	Exposure to all dosages and delivery forms.
DRUG	Venlafaxine	Exposure to all dosages and delivery forms.
DRUG	Citalopram	Exposure to all dosages and delivery forms.
DRUG	Escitalopram	Exposure to all dosages and delivery forms.
DRUG	Fluoxetine	Exposure to all dosages and delivery forms.
DRUG	Fluvoxamine	Exposure to all dosages and delivery forms.
DRUG	Paroxetine	Exposure to all dosages and delivery forms.
DRUG	Sertraline	Exposure to all dosages and delivery forms.
DRUG	Vilazodone	Exposure to all dosages and delivery forms.
DRUG	Doxepin	Exposure to all dosages and delivery forms.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2016-09-08
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States