Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT02893371

Collaborator

Patient-Centered Outcomes Research Institute (Other), Montana State University (Other), National Alliance on Mental Illness Montana (Other), CGStat LLC (Other), Risk Benefit Statistics LLC (Industry), National Alliance on Mental Illness New Mexico (Other), National Alliance on Mental Illness Westside Los Angeles (Other)

1,037,352

Enrollment

Location

33.9

Actual Duration (Months)

30595.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Lithium Carbonate Drug: Lamotrigine Drug: Valproic Acid Drug: Oxcarbazepine Drug: Carbamazepine Drug: Ziprasidone Drug: Risperidone Drug: Quetiapine Drug: Olanzapine Drug: Aripiprazole Drug: Fluoxetine / Olanzapine Drug: Haloperidol Drug: Perphenazine Drug: Clozapine Drug: Asenapine Drug: Lurasidone Drug: Paliperidone Drug: Mirtazapine Drug: Bupropion Drug: Desvenlafaxine Drug: Duloxetine Drug: Venlafaxine Drug: Citalopram Drug: Escitalopram Drug: Fluoxetine Drug: Fluvoxamine Drug: Paroxetine Drug: Sertraline Drug: Vilazodone Drug: Doxepin

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1037352 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Outcome Measures

Primary Outcome Measures

Risk of hospitalization [0-7 years]
For each treatment, assess the risk of rehospitalization within 30-days after hospitalization for a mood episode. For each treatment, assess the cumulative incidence of hospitalization for a mood episode any time after commencing treatment, accounting for the competing risk of ending treatment.
Risk of suicide and self-harm [0-7 years]
For each treatment, assess the cumulative risk of a second suicide or self-harm event after diagnosis of a first event, accounting for the competing risk of ending treatment. Self-harm includes injuries of unknown intent.

Secondary Outcome Measures

Kidney disease [0-7 years]
For each treatment, assess time to first instance of renal condition.
Diabetes mellitus [0-7 years]
For each treatment, assess time to diagnosis of diabetes mellitus