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

dc.contributor.author Reeves, GM
dc.contributor.author Keeton, C
dc.contributor.author Correll, CU
dc.contributor.author Johnson, JL
dc.contributor.author Hamer, RM
dc.contributor.author Sikich, L
dc.contributor.author Hazzard, L
dc.contributor.author Alderman, C
dc.contributor.author Scheer, A
dc.contributor.author Mabe, M
dc.contributor.author Kapoor, S
dc.contributor.author Sheridan, E
dc.contributor.author Borner, I
dc.contributor.author Bussell, K
dc.contributor.author Pirmohamed, S
dc.contributor.author Bethea, TC
dc.contributor.author Chekuri, R
dc.contributor.author Gottfried, R
dc.contributor.author Reinblatt, SP
dc.contributor.author Santana, E
dc.contributor.author Riddle, MA
dc.coverage.spatial England
dc.date.accessioned 2016-12-07T01:41:53Z
dc.date.issued 2013-08-15
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/23947389
dc.identifier 1753-2000-7-31
dc.identifier.uri http://hdl.handle.net/10161/13225
dc.description.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.
dc.language eng
dc.relation.ispartof Child Adolesc Psychiatry Ment Health
dc.relation.isversionof 10.1186/1753-2000-7-31
dc.title Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods.
dc.type Journal article
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/23947389
pubs.begin-page 31
pubs.issue 1
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Psychiatry, Child & Family Mental Health and Developmental Neuroscience
pubs.organisational-group Psychiatry & Behavioral Sciences
pubs.organisational-group School of Medicine
pubs.publication-status Published online
pubs.volume 7


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