Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods

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  • Reeves, Gloria M
    • Other Affiliation: Division of Child and Adolescent Psychiatry, School of Medicine, University of Maryland, 701 W Pratt Street, Baltimore, MD 21201, USA
  • Keeton, Courtney
    • Other Affiliation: Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, School of Medicine, Johns Hopkins University, Bloomberg Children’s Tower 12th Floor, 1800 Orleans Street, Baltimore, MD 21287, USA
  • Correll, Christoph U
    • Other Affiliation: Division of Psychiatric Research, North Shore – Long Island Jewish Health System, Zucker Hillside Hospital, 75-59 263rd St, Glen Oaks, NY 11004, USA
  • Johnson, Jacqueline
    • Affiliation: School of Medicine, Department of Psychiatry
  • Hamer, Robert
    • Affiliation: School of Medicine, Department of Psychiatry
  • Sikich, Linmarie
    • Affiliation: School of Medicine, Department of Psychiatry
  • Hazzard, Lindsey
    • Affiliation: School of Medicine, Department of Psychiatry
  • Alderman, Cheryl
    • Affiliation: School of Medicine, Department of Psychiatry
  • Scheer, Abigail
    • Affiliation: School of Medicine, Department of Psychiatry
  • Mabe, Micah
    • Affiliation: School of Medicine, Department of Psychiatry
  • Kapoor, Sandeep
    • Other Affiliation: Division of Psychiatric Research, North Shore – Long Island Jewish Health System, Zucker Hillside Hospital, 75-59 263rd St, Glen Oaks, NY 11004, USA
  • Sheridan, Eva
    • Other Affiliation: Division of Psychiatric Research, North Shore – Long Island Jewish Health System, Zucker Hillside Hospital, 75-59 263rd St, Glen Oaks, NY 11004, USA
  • Borner, Irmgard
    • Other Affiliation: Division of Psychiatric Research, North Shore – Long Island Jewish Health System, Zucker Hillside Hospital, 75-59 263rd St, Glen Oaks, NY 11004, USA
  • Bussell, Kristin
    • Other Affiliation: Division of Child and Adolescent Psychiatry, School of Medicine, University of Maryland, 701 W Pratt Street, Baltimore, MD 21201, USA
  • Pirmohamed, Sara
    • Other Affiliation: Division of Child and Adolescent Psychiatry, School of Medicine, University of Maryland, 701 W Pratt Street, Baltimore, MD 21201, USA
  • Bethea, Terrence C
    • Affiliation: School of Medicine, Department of Psychiatry
  • Chekuri, Raja
    • Other Affiliation: Division of Psychiatric Research, North Shore – Long Island Jewish Health System, Zucker Hillside Hospital, 75-59 263rd St, Glen Oaks, NY 11004, USA
  • Gottfried, Rhoda
    • Other Affiliation: Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, School of Medicine, Johns Hopkins University, Bloomberg Children’s Tower 12th Floor, 1800 Orleans Street, Baltimore, MD 21287, USA
  • Reinblatt, Shauna P
    • Other Affiliation: Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, School of Medicine, Johns Hopkins University, Bloomberg Children’s Tower 12th Floor, 1800 Orleans Street, Baltimore, MD 21287, USA
  • Santana, Erin
    • Other Affiliation: Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, School of Medicine, Johns Hopkins University, Bloomberg Children’s Tower 12th Floor, 1800 Orleans Street, Baltimore, MD 21287, USA
  • Riddle, Mark A
    • Other Affiliation: Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, School of Medicine, Johns Hopkins University, Bloomberg Children’s Tower 12th Floor, 1800 Orleans Street, Baltimore, MD 21287, USA
Abstract
  • Abstract Background Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain. Methods The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research. Results The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8–19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth. Conclusion Antipsychotic-related weight gain is an important public health issue for youth requiring ongoing antipsychotic treatment to maintain psychiatric stability. The IMPACT study provides a model for pediatric research on adverse event management using state-of-the art methods. The results of this study will provide needed data on risks and benefits of two pharmacologic interventions that are already being used in pediatric clinical settings but that have not yet been compared directly in randomized trials. Trial registration Clinical Trials.gov NCT00806234
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  • Article
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  • In Copyright
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  • Gloria M Reeves et al.; licensee BioMed Central Ltd.
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Journal title
  • Child and Adolescent Psychiatry and Mental Health
Journal volume
  • 7
Journal issue
  • 1
Page start
  • 31
Language
  • English
Is the article or chapter peer-reviewed?
  • Yes
ISSN
  • 1753-2000
Bibliographic citation
  • Child and Adolescent Psychiatry and Mental Health. 2013 Aug 15;7(1):31
Publisher
  • BioMed Central Ltd
Access right
  • Open Access
Date uploaded
  • October 1, 2013

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