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

Publication ,  Journal Article
Reeves, GM; Keeton, C; Correll, CU; Johnson, JL; Hamer, RM; Sikich, L; Hazzard, L; Alderman, C; Scheer, A; Mabe, M; Kapoor, S; Sheridan, E ...
Published in: Child Adolesc Psychiatry Ment Health
August 15, 2013

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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Published In

Child Adolesc Psychiatry Ment Health

DOI

ISSN

1753-2000

Publication Date

August 15, 2013

Volume

7

Issue

1

Start / End Page

31

Location

England

Related Subject Headings

  • Developmental & Child Psychology
  • 5203 Clinical and health psychology
  • 5202 Biological psychology
  • 5201 Applied and developmental psychology
  • 1701 Psychology
 

Citation

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Reeves, G. M., Keeton, C., Correll, C. U., Johnson, J. L., Hamer, R. M., Sikich, L., … Riddle, M. A. (2013). Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods. Child Adolesc Psychiatry Ment Health, 7(1), 31. https://doi.org/10.1186/1753-2000-7-31
Reeves, Gloria M., Courtney Keeton, Christoph U. Correll, Jacqueline L. Johnson, Robert M. Hamer, Linmarie Sikich, Lindsey Hazzard, et al. “Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods.Child Adolesc Psychiatry Ment Health 7, no. 1 (August 15, 2013): 31. https://doi.org/10.1186/1753-2000-7-31.
Reeves GM, Keeton C, Correll CU, Johnson JL, Hamer RM, Sikich L, et al. Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods. Child Adolesc Psychiatry Ment Health. 2013 Aug 15;7(1):31.
Reeves, Gloria M., et al. “Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods.Child Adolesc Psychiatry Ment Health, vol. 7, no. 1, Aug. 2013, p. 31. Pubmed, doi:10.1186/1753-2000-7-31.
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 SP, Santana E, Riddle MA. Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods. Child Adolesc Psychiatry Ment Health. 2013 Aug 15;7(1):31.
Journal cover image

Published In

Child Adolesc Psychiatry Ment Health

DOI

ISSN

1753-2000

Publication Date

August 15, 2013

Volume

7

Issue

1

Start / End Page

31

Location

England

Related Subject Headings

  • Developmental & Child Psychology
  • 5203 Clinical and health psychology
  • 5202 Biological psychology
  • 5201 Applied and developmental psychology
  • 1701 Psychology