Metabolic Effects of Second Generation Antipsychotics in Youth, Subprojects 1, 2, and 3

    Basic Details
    Date Posted
    Wednesday, January 31, 2018
    Status
    Complete
    Medical Product
    aripiprazole
    olanzapine
    quetiapine
    risperidone
    second generation antipsychotic (SGA)
    Health Outcome(s)
    metabolic syndrome
    type 2 diabetes mellitus
    weight gain
    Description

    Subprojects 1 and 2

    Protocol-based one-time assessment of the association between use of second generation antipsychotics (SGAs) in youth and adverse metabolic effects, including type 2 diabetes and the metabolic syndrome. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

    The Mini-Sentinel Operations Center posted this protocol for public comment from September 11, 2013, through September 25, 2013. A revised version was approved for implementation by FDA on November 21, 2013. A log of changes is included in the revised protocol. These projects have been completed; the final project reports were posted on July 31, 2014.

    Subproject 3

    Protocol-based one-time assessment to determine the average change in body mass index (BMI) z-score among youth initiating monotherapy treatment with olanzapine, quetiapine or risperidone compared to aripiprazole between baseline (treatment initiation) and: (i) 12 weeks (+/- 2 weeks), and (ii) 52 weeks (+/- 8 weeks) in the Mini-Sentinel Distributed Database (MSDD) population. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

    The Mini-Sentinel Operations Center posted this final draft protocol for public comment from October 31, 2014, through November 14, 2014. The public comment period is now closed. A revised version was approved for implementation by FDA on January 14, 2016. A log of changes is included in the revised protocol. This project has been completed; the final project report was posted on February 2, 2018.

    Additional Details
    FDA Center
    CDER
    Time Period
    Projects 1-2: 2001-2005; Project 3: 2006-2012
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    Population / Cohort
    Projects 1-2: All individuals 2 to 24 years of age; Project 3: All individuals 2 to 18 years of age
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Subprojects 1 and 2

    Tobias Gerhard PhD, MSc; Rutgers University Institute for Health, New Brunswick, NJ

    Marsha Raebel PharmD; Kaiser Permanente Colorado, Denver, CO

    Subproject 3 

    Ann W. McMahon MD, MS; Office of Pediatric Therapeutics, Office of the Commissioner, FDA, Silver Spring, MD

    Robert Penfold PhD; Group Health Research Institute, Seattle, WA

    Diqiong Xie PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD 

     

    Workgroup Members

    Melissa L Andersen MSc; J. Gene Hart MSc; Susan Shortreed PhD; Group Health Research Institute, Seattle, WA 

    Susan Andrade ScD; Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA 

    William Bobo MD, MPH; Vanderbilt University School of Medicine, Nashville, TN

    Chadi Calarge MD; Jess Fiedorowicz MD, PhD; University of Iowa, College of Medicine, Iowa City, IA

    Christoph Correll MD; Stephen Crystal PhD; Rutgers University Institute for Health, New Brunswick, NJ 

    Kristin Goddard MPH; Susan Shetterly MS; Kaiser Permanente Colorado, Denver, CO  

    Christine Y. Lu PhD, MSc; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Ali Mohamadi MD; Simone Pinheiro ScD, MSc; Marsha Reichman PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Zhiying You MD, PhD; University of Alabama at Birmingham, Birmingham, AL