Evidence mapPaperPMID 23947389Full record

ArticleChild and adolescent psychiatry and mental health2013

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 and 11 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Child and adolescent psychiatry and mental health, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00806234 phase4completednot on this map

Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT)

TypeinterventionalSponsorJohns Hopkins UniversityRan2009 to 2014Enrolled127ConditionsPsychotic DisordersArmsAripiprazole or Perphenazine, Metformin, Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine
NCT02877823 nacompletednot on this mapstarted 2016, after this paper: background citation

A Community-based, Family Navigator Intervention to Improve Cardiometabolic Health of Medicaid-insured Youth Identified Through an Antipsychotic Medication Preauthorization Program

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2016 to 2021Enrolled302ConditionsChildhood ObesityArmsTreatment, Control
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Behavioral Weight Loss Treatment in Antipsychotic Treated Youth.Scandinavian journal of child and adolescent psychiatry and psychology · 2016
    Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 6 institutions in 1 country.

Gloria M ReevesDivision of Child and Adolescent Psychiatry, School of Medicine, University of Maryland, 701 W Pratt Street, Baltimore, MD 21201, USA. greeves@psych.umaryland.edu.
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 P Reinblatt
Erin Santana
Mark A Riddle
University of North Carolina at Chapel Hill · USJohns Hopkins University · USUniversity of Maryland, Baltimore · USZucker Hillside Hospital · USBloomberg (United States) · USNorthwell Health · US

Funding

NIMH NIH HHS K23 MH083000NIMH NIH HHS R01 MH080325
6 · The paper itself

Abstract

backgroundYouth 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.

methodsThe 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.

resultsThe 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.

conclusionAntipsychotic-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 registrationClinical Trials.gov NCT00806234.

Identifiers

PMID23947389
PMCPMC3846140
OpenAlexW2129266152

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.