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Trial record 82 of 89 for:    DESVENLAFAXINE

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02893371
Recruitment Status : Unknown
Verified October 2017 by Christophe Gerard Lambert, University of New Mexico.
Recruitment status was:  Enrolling by invitation
First Posted : September 8, 2016
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Montana State University
National Alliance on Mental Illness
CGStat LLC
Risk Benefit Statistics LLC
Information provided by (Responsible Party):
Christophe Gerard Lambert, University of New Mexico

Tracking Information
First Submitted Date August 30, 2016
First Posted Date September 8, 2016
Last Update Posted Date October 13, 2017
Study Start Date September 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2017)
  • Risk of hospitalization [ Time Frame: 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 [ Time Frame: 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.
  • Frequency of manic and depressive mood episodes [ Time Frame: 0-7 years ]
    Assess the number of mood episodes per days on treatment.
  • All-cause mortality [ Time Frame: 0-7 years ]
    For each treatment, assess time to death
Original Primary Outcome Measures
 (submitted: September 7, 2016)
  • Risk of hospitalization [ Time Frame: 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 [ Time Frame: 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.
  • Frequency of manic and depressive mood episodes [ Time Frame: 0-7 years ]
    Assess the number of mood episodes per days on treatment.
  • All-cause mortality [ Time Frame: 0-7 years ]
Change History Complete list of historical versions of study NCT02893371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 12, 2017)
  • Kidney disease [ Time Frame: 0-7 years ]
    For each treatment, assess time to first instance of renal condition.
  • Metabolic syndrome [ Time Frame: 0-7 years ]
    For each treatment, assess time to diagnosis of metabolic syndrome.
Original Secondary Outcome Measures
 (submitted: September 7, 2016)
  • Kidney disease [ Time Frame: 0-7 years ]
  • Metabolic syndrome [ Time Frame: 0-7 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Official Title Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Brief Summary The objective of this retrospective observational study is to compare commonly prescribed bipolar disorder medications for their impact on: (1) all-cause mortality; (2) hospitalization; (3) mood episodes; (4) suicide attempts and self-harm; and (5) risk of drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. 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.
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 100 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 1.3 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) all-cause mortality; (2) risk of hospitalization; (3) frequency of manic and depressive mood episodes; (4) risk of suicide attempts and self-harm; and (5) risk of drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. In addition, the investigators will examine heterogeneity of treatment effect by co-morbidity within pediatric, adult, and elderly sub-populations.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 2003-2015.
Condition Bipolar Disorder
Intervention
  • Drug: Lithium Carbonate
    Exposure to all dosages and delivery forms.
    Other Name: Lithobid
  • Drug: Lamotrigine
    Exposure to all dosages and delivery forms.
    Other Name: Lamictal
  • Drug: Valproic Acid
    Exposure to all dosages and delivery forms.
    Other Names:
    • Depakote
    • Valproate
  • Drug: Oxcarbazepine
    Exposure to all dosages and delivery forms.
    Other Name: Trileptal
  • Drug: Carbamazepine
    Exposure to all dosages and delivery forms.
    Other Name: Equetro
  • Drug: Ziprasidone
    Exposure to all dosages and delivery forms.
    Other Name: Geodon
  • Drug: Risperidone
    Exposure to all dosages and delivery forms.
    Other Name: Risperdal
  • Drug: Quetiapine
    Exposure to all dosages and delivery forms.
    Other Name: Seroquel
  • Drug: Olanzapine
    Exposure to all dosages and delivery forms.
    Other Name: Zyprexa
  • Drug: Aripiprazole
    Exposure to all dosages and delivery forms.
    Other Name: Abilify
  • Drug: Fluoxetine / Olanzapine
    Exposure to all dosages and delivery forms.
    Other Name: Symbyax
  • Drug: Haloperidol
    Exposure to all dosages and delivery forms.
    Other Name: Haldol Decanoate
  • Drug: Perphenazine
    Exposure to all dosages and delivery forms.
    Other Name: Trilafon
  • Drug: Clozapine
    Exposure to all dosages and delivery forms.
    Other Name: Clozaril
  • Drug: Asenapine
    Exposure to all dosages and delivery forms.
    Other Name: Saphris
  • Drug: Lurasidone
    Exposure to all dosages and delivery forms.
    Other Name: Latuda
  • Drug: Paliperidone
    Exposure to all dosages and delivery forms.
    Other Name: Invega
  • Drug: Mirtazapine
    Exposure to all dosages and delivery forms.
    Other Names:
    • Remeron
    • Remeronsoltab
  • Drug: Bupropion
    Exposure to all dosages and delivery forms.
    Other Names:
    • Zyban
    • Aplenzin
    • Wellbutrin
  • Drug: Desvenlafaxine
    Exposure to all dosages and delivery forms.
    Other Names:
    • Pristiq
    • Desfax
  • Drug: Duloxetine
    Exposure to all dosages and delivery forms.
    Other Names:
    • Cymbalta
    • Irenka
  • Drug: Venlafaxine
    Exposure to all dosages and delivery forms.
    Other Name: Effexor XR
  • Drug: Citalopram
    Exposure to all dosages and delivery forms.
    Other Name: Celexa
  • Drug: Escitalopram
    Exposure to all dosages and delivery forms.
    Other Name: Lexapro
  • Drug: Fluoxetine
    Exposure to all dosages and delivery forms.
    Other Names:
    • Prozac
    • Sarafem
  • Drug: Fluvoxamine
    Exposure to all dosages and delivery forms.
    Other Names:
    • Faverin
    • Fevarin
    • Floxyfral
    • Dumyrox
    • Luvox
  • Drug: Paroxetine
    Exposure to all dosages and delivery forms.
    Other Names:
    • Paxil
    • Seroxat
  • Drug: Sertraline
    Exposure to all dosages and delivery forms.
    Other Name: Zoloft
  • Drug: Vilazodone
    Exposure to all dosages and delivery forms.
    Other Name: Viibryd
  • Drug: Doxepin
    Exposure to all dosages and delivery forms.
    Other Names:
    • Sinequan
    • Silenor
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 12, 2017)
1300000
Original Estimated Enrollment
 (submitted: September 7, 2016)
1000000
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02893371
Other Study ID Numbers 16-243
CER-1507-31607 ( Other Grant/Funding Number: PCORI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Christophe Gerard Lambert, University of New Mexico
Study Sponsor University of New Mexico
Collaborators
  • Patient-Centered Outcomes Research Institute
  • Montana State University
  • National Alliance on Mental Illness
  • CGStat LLC
  • Risk Benefit Statistics LLC
Investigators
Principal Investigator: Christophe G Lambert, PhD University of New Mexico Health Sciences Center
PRS Account University of New Mexico
Verification Date October 2017