Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

NCT02893371 | Terminated

• 2 other identifiers: 16-243CER-1507-31607
• Study Type: observational
• Target: 1,037,352
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Kidney disease

  0-7 years

• Diabetes mellitus

  0-7 years

Interventions

Lithium Carbonate DRUG

Exposure to all dosages and delivery forms.

Also known as: Lithobid

Lamotrigine DRUG

Exposure to all dosages and delivery forms.

Also known as: Lamictal

Valproic Acid DRUG

Exposure to all dosages and delivery forms.

Also known as: Depakote, Valproate

Oxcarbazepine DRUG

Exposure to all dosages and delivery forms.

Also known as: Trileptal

Carbamazepine DRUG

Exposure to all dosages and delivery forms.

Also known as: Equetro

Ziprasidone DRUG

Exposure to all dosages and delivery forms.

Also known as: Geodon

Risperidone DRUG

Exposure to all dosages and delivery forms.

Also known as: Risperdal

Quetiapine DRUG

Exposure to all dosages and delivery forms.

Also known as: Seroquel

Olanzapine DRUG

Exposure to all dosages and delivery forms.

Also known as: Zyprexa

Aripiprazole DRUG

Exposure to all dosages and delivery forms.

Also known as: Abilify

Fluoxetine / Olanzapine DRUG

Exposure to all dosages and delivery forms.

Also known as: Symbyax

Haloperidol DRUG

Exposure to all dosages and delivery forms.

Also known as: Haldol Decanoate

Perphenazine DRUG

Exposure to all dosages and delivery forms.

Also known as: Trilafon

Clozapine DRUG

Exposure to all dosages and delivery forms.

Also known as: Clozaril

Asenapine DRUG

Exposure to all dosages and delivery forms.

Also known as: Saphris

Lurasidone DRUG

Exposure to all dosages and delivery forms.

Also known as: Latuda

Paliperidone DRUG

Exposure to all dosages and delivery forms.

Also known as: Invega

Mirtazapine DRUG

Exposure to all dosages and delivery forms.

Also known as: Remeron, Remeronsoltab

Bupropion DRUG

Exposure to all dosages and delivery forms.

Also known as: Zyban, Aplenzin, Wellbutrin

Desvenlafaxine DRUG

Exposure to all dosages and delivery forms.

Also known as: Pristiq, Desfax

Duloxetine DRUG

Exposure to all dosages and delivery forms.

Also known as: Cymbalta, Irenka

Venlafaxine DRUG

Exposure to all dosages and delivery forms.

Also known as: Effexor XR

Citalopram DRUG

Exposure to all dosages and delivery forms.

Also known as: Celexa

Escitalopram DRUG

Exposure to all dosages and delivery forms.

Also known as: Lexapro

Fluoxetine DRUG

Exposure to all dosages and delivery forms.

Also known as: Prozac, Sarafem

Fluvoxamine DRUG

Exposure to all dosages and delivery forms.

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

Paroxetine DRUG

Exposure to all dosages and delivery forms.

Also known as: Paxil, Seroxat

Sertraline DRUG

Exposure to all dosages and delivery forms.

Also known as: Zoloft

Vilazodone DRUG

Exposure to all dosages and delivery forms.

Also known as: Viibryd

Doxepin DRUG

Exposure to all dosages and delivery forms.

Also known as: Sinequan, Silenor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of New Mexico: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Montana State University: collaborator
• National Alliance on Mental Illness Montana: collaborator
• CGStat LLC: collaborator
• Risk Benefit Statistics LLC: collaborator
• National Alliance on Mental Illness New Mexico: collaborator
• National Alliance on Mental Illness Westside Los Angeles: collaborator

Study Sites (1)

Christophe G Lambert

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (7)

• 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.

  PMID: 28901625 RESULT

• 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.

  PMID: 29920885 RESULT

• 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.

  PMID: 30986735 RESULT

• 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.

  PMID: 31237566 RESULT

• 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.

  PMID: 31651956 RESULT

• 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.

  PMID: 31744781 RESULT

• 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.

  PMID: 33688834 RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium Carbonate; Lamotrigine; Valproic Acid; Oxcarbazepine; Carbamazepine; ziprasidone; Risperidone; Quetiapine Fumarate; Olanzapine; Aripiprazole; olanzapine-fluoxetine combination; Haloperidol; Perphenazine; Clozapine; asenapine; Lurasidone Hydrochloride; Paliperidone Palmitate; Mirtazapine; Bupropion; Desvenlafaxine Succinate; Duloxetine Hydrochloride; Venlafaxine Hydrochloride; Citalopram; Escitalopram; Fluoxetine; Fluvoxamine; Paroxetine; Sertraline; Vilazodone Hydrochloride; Doxepin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Piperazines; Quinolones; Quinolines; Butyrophenones; Ketones; Phenothiazines; Thiazoles; Azoles; Isoindoles; Isoxazoles; Propiophenones; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Thiophenes; Phenethylamines; Ethylamines; Amines; Propylamines; Nitriles; Benzofurans; Oximes; Hydroxylamines; Piperidines; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indoles; Oxepins; Ethers, Cyclic; Ethers; Dibenzoxepins

Study Officials

• Christophe G Lambert, PhD

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)