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

Gloria M. Reeves, Courtney Keeton, Christoph U. Correll, Jacqueline L. Johnson, Robert M. Hamer, Linmarie Sikich, Lindsey Hazzard, Cheryl Alderman, Abigail Scheer, Micah Mabe, Sandeep Kapoor, Eva Sheridan, Irmgard Borner, Kristin Bussell, Sara Pirmohamed, Terrence C. Bethea, Raja Chekuri, Rhoda Gottfried, Shauna Reinblatt, Erin SantanaMark A Riddle

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number31
JournalChild and Adolescent Psychiatry and Mental Health
Volume7
Issue number1
DOIs
StatePublished - Aug 15 2013

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Antipsychotic Agents
Weight Gain
Therapeutics
Psychiatry
Pediatrics
Education
Research
Clinical Trials
Metformin
Major Depressive Disorder
Autistic Disorder
Bipolar Disorder
Sample Size
Insulin Resistance
Adipose Tissue
Weight Loss
Schizophrenia
Body Mass Index
Public Health
Lipids

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health

Cite this

Improving metabolic parameters of antipsychotic child treatment (IMPACT) study : Rationale, design, and methods. / Reeves, Gloria M.; Keeton, Courtney; Correll, Christoph U.; Johnson, Jacqueline L.; Hamer, Robert M.; Sikich, Linmarie; Hazzard, Lindsey; Alderman, Cheryl; Scheer, Abigail; Mabe, Micah; Kapoor, Sandeep; Sheridan, Eva; Borner, Irmgard; Bussell, Kristin; Pirmohamed, Sara; Bethea, Terrence C.; Chekuri, Raja; Gottfried, Rhoda; Reinblatt, Shauna; Santana, Erin; Riddle, Mark A.

In: Child and Adolescent Psychiatry and Mental Health, Vol. 7, No. 1, 31, 15.08.2013.

Research output: Contribution to journalArticle

Reeves, GM, Keeton, C, Correll, CU, Johnson, JL, Hamer, RM, Sikich, L, Hazzard, L, Alderman, C, Scheer, A, Mabe, M, Kapoor, S, Sheridan, E, Borner, I, Bussell, K, Pirmohamed, S, Bethea, TC, Chekuri, R, Gottfried, R, Reinblatt, S, Santana, E & Riddle, MA 2013, 'Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: Rationale, design, and methods', Child and Adolescent Psychiatry and Mental Health, vol. 7, no. 1, 31. https://doi.org/10.1186/1753-2000-7-31
Reeves, Gloria M. ; Keeton, Courtney ; Correll, Christoph U. ; Johnson, Jacqueline L. ; Hamer, Robert M. ; Sikich, Linmarie ; Hazzard, Lindsey ; Alderman, Cheryl ; Scheer, Abigail ; Mabe, Micah ; Kapoor, Sandeep ; Sheridan, Eva ; Borner, Irmgard ; Bussell, Kristin ; Pirmohamed, Sara ; Bethea, Terrence C. ; Chekuri, Raja ; Gottfried, Rhoda ; Reinblatt, Shauna ; Santana, Erin ; Riddle, Mark A. / Improving metabolic parameters of antipsychotic child treatment (IMPACT) study : Rationale, design, and methods. In: Child and Adolescent Psychiatry and Mental Health. 2013 ; Vol. 7, No. 1.
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