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  1. Article: Early pharmacological treatment of autism: a rationale for developmental treatment.

    Bethea, Terrence C / Sikich, Linmarie

    Biological psychiatry

    2007  Volume 61, Issue 4, Page(s) 521–537

    Abstract: Autism is a dynamic neurodevelopmental syndrome in which disabilities emerge during the first three postnatal years and continue to evolve with ongoing development. We briefly review research in autism describing subtle changes in molecules important in ... ...

    Abstract Autism is a dynamic neurodevelopmental syndrome in which disabilities emerge during the first three postnatal years and continue to evolve with ongoing development. We briefly review research in autism describing subtle changes in molecules important in brain development and neurotransmission, in morphology of specific neurons, brain connections, and in brain size. We then provide a general schema of how these processes may interact with particular emphasis on neurotransmission. In this context, we present a rationale for utilizing pharmacologic treatments aimed at modifying key neurodevelopmental processes in young children with autism. Early treatment with selective serotonin reuptake inhibitors (SSRIs) is presented as a model for pharmacologic interventions because there is evidence in autistic children for reduced brain serotonin synthesis during periods of peak synaptogenesis; serotonin is known to enhance synapse refinement; and exploratory studies with these agents in autistic children exist. Additional hypothetical developmental interventions and relevant published clinical data are described. Finally, we discuss the importance of exploring early pharmacologic interventions within multiple experimental settings in order to develop effective treatments as quickly as possible while minimizing risks.
    MeSH term(s) Animals ; Autistic Disorder/drug therapy ; Autistic Disorder/metabolism ; Autistic Disorder/pathology ; Brain/drug effects ; Brain/growth & development ; Brain/metabolism ; Brain/pathology ; Early Intervention (Education) ; Humans ; Neurotransmitter Agents/metabolism ; Serotonin Uptake Inhibitors/therapeutic use
    Chemical Substances Neurotransmitter Agents ; Serotonin Uptake Inhibitors
    Language English
    Publishing date 2007-02-15
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 209434-4
    ISSN 1873-2402 ; 0006-3223
    ISSN (online) 1873-2402
    ISSN 0006-3223
    DOI 10.1016/j.biopsych.2006.09.021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Pilot Study of an Active Screen Time Game Correlates with Improved Physical Fitness in Minority Elementary School Youth.

    Bethea, Terrence C / Berry, Diane / Maloney, Ann E / Sikich, Linmarie

    Games for health journal

    2012  Volume 1, Issue 1, Page(s) 29–36

    Abstract: Objective: The aim of our feasibility study was to examine the acceptability and utility of "Dance Dance Revolution" (DDR) (Konami of America, Redwood City, CA)) to increase physical fitness in 8-11-year-old black and Hispanic youth.: Subjects and ... ...

    Abstract Objective: The aim of our feasibility study was to examine the acceptability and utility of "Dance Dance Revolution" (DDR) (Konami of America, Redwood City, CA)) to increase physical fitness in 8-11-year-old black and Hispanic youth.
    Subjects and methods: Twenty-eight 4(th) and 5(th) grade children attending an afterschool program participated. Outcomes included physical activity, physical fitness, use of home DDR, survey of safety and acceptability, anthropometrics, and fasting metabolic profile measured at baseline, 12 weeks, and 30 weeks.
    Results: At 12 weeks, physical fitness (maximum O2 uptake [VO2max]) increased by 4.9±9.9 percent and was sustained through 30 weeks, when the VO2max was 105.0±9.9 percent (range, 93.0-133.9 percent) of baseline values. Absolute VO2max increased by 2.97±4.99 mL/kg/minute (95% confidence interval 0.75-5.19, P=0.013). Participants maintained an average of 1.12 hours/day of increased movement to music. Trends suggested increased total moderate-vigorous physical activity, decreased light activity, and a modest increase in sedentary screen time. There were no significant changes in body mass index, fasting lipids, or glucose. Participants and parents approved of the activity.
    Conclusion: DDR appears feasible and acceptable to minority youth. DDR may increase moderate-vigorous physical activity and improve physical fitness in at-risk populations.
    Language English
    Publishing date 2012-01-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2650543-5
    ISSN 2161-7856 ; 2161-783X
    ISSN (online) 2161-7856
    ISSN 2161-783X
    DOI 10.1089/g4h.2011.0005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Metformin add-on vs. antipsychotic switch vs. continued antipsychotic treatment plus healthy lifestyle education in overweight or obese youth with severe mental illness: results from the IMPACT trial.

    Correll, Christoph U / Sikich, Linmarie / Reeves, Gloria / Johnson, Jacqueline / Keeton, Courtney / Spanos, Marina / Kapoor, Sandeep / Bussell, Kristin / Miller, Leslie / Chandrasekhar, Tara / Sheridan, Eva M / Pirmohamed, Sara / Reinblatt, Shauna P / Alderman, Cheryl / Scheer, Abigail / Borner, Irmgard / Bethea, Terrence C / Edwards, Sarah / Hamer, Robert M /
    Riddle, Mark A

    World psychiatry : official journal of the World Psychiatric Association (WPA)

    2020  Volume 19, Issue 1, Page(s) 69–80

    Abstract: Antipsychotics are used for many psychiatric conditions in youth. Although developmentally inappropriate weight gain and metabolic abnormalities, which are risk factors for premature cardiovascular mortality, are especially frequent in youth, optimal ... ...

    Abstract Antipsychotics are used for many psychiatric conditions in youth. Although developmentally inappropriate weight gain and metabolic abnormalities, which are risk factors for premature cardiovascular mortality, are especially frequent in youth, optimal strategies to reduce pediatric antipsychotic-induced overweight/obesity are unclear. The Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) was a randomized, parallel group, 24-week clinical trial which enrolled overweight/obese, psychiatrically stable youth, aged 8-19 years, with a DSM-IV diagnosis of severe mental illness (schizophrenia spectrum disorder, bipolar spectrum disorder or psychotic depression), at four US universities. All of them had developed substantial weight gain following treatment with a second-generation antipsychotic. The centralized, computer-based randomization system assigned participants to unmasked treatment groups: metformin (MET); antipsychotic switch (aripiprazole or, if already exposed to that drug, perphenazine or molindone; SWITCH); or continued baseline antipsychotic (CONTROL). All participants received healthy lifestyle education. The primary outcome was body mass index (BMI) z-score change from baseline, analyzed using estimated least squares means. Altogether, 127 participants were randomized: 49 to MET, 31 to SWITCH, and 47 to CONTROL. BMI z-score decreased significantly with MET (week 24: -0.09±0.03, p=0.002) and SWITCH (week 24: -0.11±0.04, p=0.003), while it increased non-significantly with CONTROL (week 24: +0.04±0.03). On 3-way comparison, BMI z-score changes differed significantly (p=0.001). MET and SWITCH were each superior to CONTROL (p=0.002), with effect sizes of 0.68 and 0.81 respectively, while MET and SWITCH did not differ. More gastrointestinal problems occurred in MET than in SWITCH or CONTROL. The data safety monitoring board closed the perphenazine-SWITCH arm because 35.2% of subjects discontinued treatment due to psychiatric worsening. These data suggest that pediatric antipsychotic-related overweight/obesity can be reduced by adding metformin or switching to a lower risk antipsychotic. Healthy lifestyle education is not sufficient to prevent ongoing BMI z-score increase.
    Language English
    Publishing date 2020-01-10
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 2236130-3
    ISSN 2051-5545 ; 1723-8617
    ISSN (online) 2051-5545
    ISSN 1723-8617
    DOI 10.1002/wps.20714
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: 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 P /
    Santana, Erin / Riddle, Mark A

    Child and adolescent psychiatry and mental health

    2013  Volume 7, Issue 1, Page(s) 31

    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 ... ...

    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.
    Language English
    Publishing date 2013-08-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 2379599-2
    ISSN 1753-2000
    ISSN 1753-2000
    DOI 10.1186/1753-2000-7-31
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