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Bipolar DisorderNCT02893371

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

An observational study of Bipolar Disorder, run by University of New Mexico at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Bipolar Disorder
What is being tested?
Lithium Carbonate, Lamotrigine and Valproic Acid
How many people
1,037,352 participants
Where
1 siteUnited States
Study dates
Sep 2016to 30 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Christophe G Lambert

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

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.

Being tested
Lithium Carbonate, Lamotrigine, Valproic Acid, Oxcarbazepine, Carbamazepine
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lithium CarbonateDrug

    Also called Lithobid

    Exposure to all dosages and delivery forms.

  • LamotrigineDrug

    Also called Lamictal

    Exposure to all dosages and delivery forms.

  • Valproic AcidDrug

    Also called Depakote, Valproate

    Exposure to all dosages and delivery forms.

  • OxcarbazepineDrug

    Also called Trileptal

    Exposure to all dosages and delivery forms.

  • CarbamazepineDrug

    Also called Equetro

    Exposure to all dosages and delivery forms.

  • ZiprasidoneDrug

    Also called Geodon

    Exposure to all dosages and delivery forms.

  • RisperidoneDrug

    Also called Risperdal

    Exposure to all dosages and delivery forms.

  • QuetiapineDrug

    Also called Seroquel

    Exposure to all dosages and delivery forms.

  • OlanzapineDrug

    Also called Zyprexa

    Exposure to all dosages and delivery forms.

  • AripiprazoleDrug

    Also called Abilify

    Exposure to all dosages and delivery forms.

  • Fluoxetine / OlanzapineDrug

    Also called Symbyax

    Exposure to all dosages and delivery forms.

  • HaloperidolDrug

    Also called Haldol Decanoate

    Exposure to all dosages and delivery forms.

  • PerphenazineDrug

    Also called Trilafon

    Exposure to all dosages and delivery forms.

  • ClozapineDrug

    Also called Clozaril

    Exposure to all dosages and delivery forms.

  • AsenapineDrug

    Also called Saphris

    Exposure to all dosages and delivery forms.

  • LurasidoneDrug

    Also called Latuda

    Exposure to all dosages and delivery forms.

  • PaliperidoneDrug

    Also called Invega

    Exposure to all dosages and delivery forms.

  • MirtazapineDrug

    Also called Remeron, Remeronsoltab

    Exposure to all dosages and delivery forms.

  • BupropionDrug

    Also called Zyban, Aplenzin, Wellbutrin

    Exposure to all dosages and delivery forms.

  • DesvenlafaxineDrug

    Also called Pristiq, Desfax

    Exposure to all dosages and delivery forms.

  • DuloxetineDrug

    Also called Cymbalta, Irenka

    Exposure to all dosages and delivery forms.

  • VenlafaxineDrug

    Also called Effexor XR

    Exposure to all dosages and delivery forms.

  • CitalopramDrug

    Also called Celexa

    Exposure to all dosages and delivery forms.

  • EscitalopramDrug

    Also called Lexapro

    Exposure to all dosages and delivery forms.

  • FluoxetineDrug

    Also called Prozac, Sarafem

    Exposure to all dosages and delivery forms.

  • FluvoxamineDrug

    Also called Faverin, Fevarin, Floxyfral, Dumyrox

    Exposure to all dosages and delivery forms.

  • ParoxetineDrug

    Also called Paxil, Seroxat

    Exposure to all dosages and delivery forms.

  • SertralineDrug

    Also called Zoloft

    Exposure to all dosages and delivery forms.

  • VilazodoneDrug

    Also called Viibryd

    Exposure to all dosages and delivery forms.

  • DoxepinDrug

    Also called Sinequan, Silenor

    Exposure to all dosages and delivery forms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 0-7 years

Secondary outcomes (2)

  1. Kidney disease

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

    Measured: 0-7 years

  2. Diabetes mellitus

    For each treatment, assess time to diagnosis of diabetes mellitus

    Measured: 0-7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Why it stopped: Per PI, this study is not a clinical trial and was inadvertently entered in the system

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,037,352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02893371
Sponsor's protocol ID
16-243
Other IDs
CER-1507-31607
Status last verified
Mar 2024
First submitted
30 Aug 2016
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Per PI, this study is not a clinical trial and was inadvertently entered in the system). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of hospitalization (time frame: 0-7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02893371, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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