Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Bipolar Disorder Clinical Trial

Official title:

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02893371
• Other study ID #: 16-243
• Secondary ID: CER-1507-31607
• Status: Terminated
• Start date: September 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1037352
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Christophe G Lambert	Albuquerque	New Mexico

Sponsors (8)

Lead Sponsor	Collaborator
University of New Mexico	CGStat LLC, Montana State University, National Alliance on Mental Illness Montana, National Alliance on Mental Illness New Mexico, National Alliance on Mental Illness Westside Los Angeles, Patient-Centered Outcomes Research Institute, Risk Benefit Statistics LLC

Country where clinical trial is conducted

United States, 

References & Publications (7)

Kerner B, Crisanti AS, DeShaw JL, Ho JG, Jordan K, Krall RL, Kuntz MJ, Mazurie AJ, Nestsiarovich A, Perkins DJ, Schroeter QL, Smith AN, Tohen M, Volesky E, Zhu Y, Lambert CG. Preferences of Information Dissemination on Treatment for Bipolar Disorder: Pati — View Citation

Kumar P, Nestsiarovich A, Nelson SJ, Kerner B, Perkins DJ, Lambert CG. Imputation and characterization of uncoded self-harm in major mental illness using machine learning. J Am Med Inform Assoc. 2020 Jan 1;27(1):136-146. doi: 10.1093/jamia/ocz173. — View Citation

Nestsiarovich A, Hurwitz NG, Nelson SJ, Crisanti AS, Kerner B, Kuntz MJ, Smith AN, Volesky E, Schroeter QL, DeShaw JL, Young SS, Obenchain RL, Krall RL, Jordan K, Fawcett J, Tohen M, Perkins DJ, Lambert CG. Systemic challenges in bipolar disorder manageme — View Citation

Nestsiarovich A, Kerner B, Mazurie AJ, Cannon DC, Hurwitz NG, Zhu Y, Nelson SJ, Oprea TI, Crisanti AS, Tohen M, Perkins DJ, Lambert CG. Diabetes mellitus risk for 102 drugs and drug combinations used in patients with bipolar disorder. Psychoneuroendocrino — View Citation

Nestsiarovich A, Kerner B, Mazurie AJ, Cannon DC, Hurwitz NG, Zhu Y, Nelson SJ, Oprea TI, Unruh ML, Crisanti AS, Tohen M, Perkins DJ, Lambert CG. Comparison of 71 bipolar disorder pharmacotherapies for kidney disorder risk: The potential hazards of polyph — View Citation

Nestsiarovich A, Kumar P, Lauve NR, Hurwitz NG, Mazurie AJ, Cannon DC, Zhu Y, Nelson SJ, Crisanti AS, Kerner B, Tohen M, Perkins DJ, Lambert CG. Using Machine Learning Imputed Outcomes to Assess Drug-Dependent Risk of Self-Harm in Patients with Bipolar Di — View Citation

Nestsiarovich A, Mazurie AJ, Hurwitz NG, Kerner B, Nelson SJ, Crisanti AS, Tohen M, Krall RL, Perkins DJ, Lambert CG. Comprehensive comparison of monotherapies for psychiatric hospitalization risk in bipolar disorders. Bipolar Disord. 2018 Dec;20(8):761-7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of hospitalization	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.	0-7 years
Primary	Risk of suicide and self-harm	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.	0-7 years
Secondary	Kidney disease	For each treatment, assess time to first instance of renal condition.	0-7 years
Secondary	Diabetes mellitus	For each treatment, assess time to diagnosis of diabetes mellitus	0-7 years