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TerminatedNCT02893371Updated Mar 12, 2024

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

An observational study in Bipolar Disorder, sponsored by University of New Mexico. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by University of New Mexico · Observational

Why this study was terminated
Per PI, this study is not a clinical trial and was inadvertently entered in the system
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,037,352
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bipolar Disorder

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 1,037,352 is above the median of 160 across 329 observational studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of individuals with bipolar disorder enrolled with private insurers or with Medicare across the United States, as captured in the Truven Health Analytics MarketScan databases. The time period of data coverage is 2003-2016.

Inclusion criteria

  • Two or more instances of bipolar disorder diagnoses within administrative claims records

Exclusion criteria

Exclusion Criteria:

  • Patients with less than 1 year of history in the database
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,037,352 participants (actual)
Patient registry
No

Interventions

  • DrugLithium Carbonate

    Exposure to all dosages and delivery forms.

    Also known as: Lithobid

  • DrugLamotrigine

    Exposure to all dosages and delivery forms.

    Also known as: Lamictal

  • DrugValproic Acid

    Exposure to all dosages and delivery forms.

    Also known as: Depakote, Valproate

  • DrugOxcarbazepine

    Exposure to all dosages and delivery forms.

    Also known as: Trileptal

  • DrugCarbamazepine

    Exposure to all dosages and delivery forms.

    Also known as: Equetro

  • DrugZiprasidone

    Exposure to all dosages and delivery forms.

    Also known as: Geodon

  • DrugRisperidone

    Exposure to all dosages and delivery forms.

    Also known as: Risperdal

  • DrugQuetiapine

    Exposure to all dosages and delivery forms.

    Also known as: Seroquel

  • DrugOlanzapine

    Exposure to all dosages and delivery forms.

    Also known as: Zyprexa

  • DrugAripiprazole

    Exposure to all dosages and delivery forms.

    Also known as: Abilify

  • DrugFluoxetine / Olanzapine

    Exposure to all dosages and delivery forms.

    Also known as: Symbyax

  • DrugHaloperidol

    Exposure to all dosages and delivery forms.

    Also known as: Haldol Decanoate

  • DrugPerphenazine

    Exposure to all dosages and delivery forms.

    Also known as: Trilafon

  • DrugClozapine

    Exposure to all dosages and delivery forms.

    Also known as: Clozaril

  • DrugAsenapine

    Exposure to all dosages and delivery forms.

    Also known as: Saphris

  • DrugLurasidone

    Exposure to all dosages and delivery forms.

    Also known as: Latuda

  • DrugPaliperidone

    Exposure to all dosages and delivery forms.

    Also known as: Invega

  • DrugMirtazapine

    Exposure to all dosages and delivery forms.

    Also known as: Remeron, Remeronsoltab

  • DrugBupropion

    Exposure to all dosages and delivery forms.

    Also known as: Zyban, Aplenzin, Wellbutrin

  • DrugDesvenlafaxine

    Exposure to all dosages and delivery forms.

    Also known as: Pristiq, Desfax

  • DrugDuloxetine

    Exposure to all dosages and delivery forms.

    Also known as: Cymbalta, Irenka

  • DrugVenlafaxine

    Exposure to all dosages and delivery forms.

    Also known as: Effexor XR

  • DrugCitalopram

    Exposure to all dosages and delivery forms.

    Also known as: Celexa

  • DrugEscitalopram

    Exposure to all dosages and delivery forms.

    Also known as: Lexapro

  • DrugFluoxetine

    Exposure to all dosages and delivery forms.

    Also known as: Prozac, Sarafem

  • DrugFluvoxamine

    Exposure to all dosages and delivery forms.

    Also known as: Faverin, Fevarin, Floxyfral, Dumyrox, Luvox

  • DrugParoxetine

    Exposure to all dosages and delivery forms.

    Also known as: Paxil, Seroxat

  • DrugSertraline

    Exposure to all dosages and delivery forms.

    Also known as: Zoloft

  • DrugVilazodone

    Exposure to all dosages and delivery forms.

    Also known as: Viibryd

  • DrugDoxepin

    Exposure to all dosages and delivery forms.

    Also known as: Sinequan, Silenor

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-7 years

  2. 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.

    Time frame: 0-7 years

Secondary outcomes

  1. Kidney disease

    For each treatment, assess time to first instance of renal condition.

    Time frame: 0-7 years

  2. Diabetes mellitus

    For each treatment, assess time to diagnosis of diabetes mellitus

    Time frame: 0-7 years

07

Study locations

1 site
  • Christophe G Lambert
    Albuquerque, New Mexico 87131, United States
08

References and documents

Publications

  • 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 management: A patient-centered approach. Bipolar Disord. 2017 Dec;19(8):676-688. doi: 10.1111/bdi.12547. Epub 2017 Sep 13. PubMed 28901625 ↗
  • 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):761-771. doi: 10.1111/bdi.12665. Epub 2018 Jun 19. PubMed 29920885 ↗
  • 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 polypharmacy. J Affect Disord. 2019 Jun 1;252:201-211. doi: 10.1016/j.jad.2019.04.009. Epub 2019 Apr 8. PubMed 30986735 ↗
  • 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: Patient-Centered Focus Group Study. JMIR Ment Health. 2019 Jun 25;6(6):e12848. doi: 10.2196/12848. PubMed 31237566 ↗
  • 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. PubMed 31651956 ↗
  • 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. Psychoneuroendocrinology. 2020 Feb;112:104511. doi: 10.1016/j.psyneuen.2019.104511. Epub 2019 Nov 9. PubMed 31744781 ↗
  • 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 Disorder: A Comparative Effectiveness Study. JMIR Ment Health. 2021 Apr 21;8(4):e24522. doi: 10.2196/24522. PubMed 33688834 ↗

Individual participant data

Plan to share: No — This retrospective observational study makes use of MarketScan individual level patient data from Truven Health Analytics. The license terms for data access prohibit public dissemination of individual level patient data. The investigators will, however, make openly available the queries and analytic procedures required to reproduce the study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02893371
Lead sponsor
University of New Mexico
Collaborators
Patient-Centered Outcomes Research Institute, Montana State University, National Alliance on Mental Illness Montana, CGStat LLC, Risk Benefit Statistics LLC, National Alliance on Mental Illness New Mexico, National Alliance on Mental Illness Westside Los Angeles
Responsible party
Christophe Gerard Lambert (Associate Professor, University of New Mexico) — Principal investigator
First posted
Sep 8, 2016
Start date
Sep 2016
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Mar 12, 2024

Study contacts

Christophe G Lambert, PhD
principal investigator · University of New Mexico Health Sciences Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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