When Adverse Childhood Experiences Present to a Statewide Child Psychiatry Access Program.

Many children experience adversity, yet few receive needed psychiatric services. Pediatric primary care providers (PCPs) are uniquely positioned to intervene but often lack training and resources to provide patients with adverse childhood experiences (ACEs) the psychiatric support they need. The current study examines characteristics of youth with and without ACEs who were the focus of PCP contacts with a statewide child psychiatry access program (CPAP). Compared to those without ACEs, patients with ACEs were more often receiving medication treatment at time of CPAP contact, prescribed two or more psychotropic medications, and diagnosed with two or more mental health disorders. Study findings indicate that patients with ACEs for whom PCPs sought CPAP support were experiencing more clinically severe and complex mental health concerns. These findings underscore the important role of CPAPs in supporting PCPs with pediatric patients who have ACEs and will inform training provided by CPAPs to PCPs.

Characteristics of Patients Served by a Statewide Child Psychiatry Access Program.

OBJECTIVE: Maryland's Behavioral Health Integration in Pediatric Primary Care (BHIPP) is a child psychiatry access program offering child-adolescent psychiatry consultation, resource and referral networking, and direct-to-patient mental health intervention. This study investigated characteristics of patients for whom primary care providers sought BHIPP services. METHODS: Data from 6,939 unique patient contacts between October 2012 and March 2020 were collected on service type, demographic characteristics, presenting concerns, clinical severity, clinicians' diagnostic impressions, current treatments, and BHIPP recommendations. Descriptive statistics and latent class analysis were used. RESULTS: Of the 6,939 patient contacts, 38.6% were for direct-to-patient mental health intervention, 27.3% for child-adolescent psychiatry consultation, and 34.2% for resource and referral networking. In total, 50.3% of patients were female, 58.7% were White, and 32.7% were already receiving mental health services. Latent class analysis identified four classes of presenting concerns: anxiety only (44.2%); behavior problems only (30.7%); mood and anxiety (17.1%); and attention, behavior, and learning problems (8.0%). Compared with patients in the anxiety-only class, those in the attention, behavior, and learning problems class were more likely to receive direct-to-patient mental health intervention (OR=3.59), and BHIPP clinicians were more likely to recommend in-office behavioral interventions for those in the mood and anxiety class (OR=1.62) and behavior problems-only class (OR=1.55). CONCLUSIONS: Patients supported through BHIPP varied in presenting concerns, condition severity and complexity, current receipt of services, and BHIPP utilization. Latent class analysis yielded more clinically useful information about the nature and complexity of patients' concerns than did consideration of individual presenting concerns.

Characteristics of Primary Care Providers' Consultations With a Statewide Child Psychiatry Access Program Regarding Autism Spectrum Disorder.

BACKGROUND: Child Psychiatry Access Programs (CPAPs) provide consultative support for pediatric primary care providers (PCPs) to treat co-morbid mental health (MH) symptoms among patients with Autism Spectrum Disorder (ASD). OBJECTIVES: We examined differences in illness severity, comorbidity, and psychotropic medication use between patients with and without ASD for whom primary care providers sought consultation from Maryland's CPAP. METHODS: We examined N = 3641 Maryland's CPAP consultations from 2012 to 2019; n = 311 were consultations for ASD. Demographics, treatment recommendations, diagnoses, and Clinical Global Impression-Severity scores were collected. Patients who received psychotropic medication or psychotherapy by any mental health provider were defined as comanaged. Descriptive statistics and logistic regression were conducted. Sample size for regression was N = 1854. RESULTS: Compared with non-ASD, patients with consults for ASD were more often male (P < 0.001), aged 0-5 years (P < 0.001), severely ill (Clinical Global Impression-Severity > 4) (P < 0.001), and prescribed stimulants, nonstimulant attention-deficit hyperactivity disorder medications, and antipsychotic medications (P < 0.001). Controlling for key covariates, consultations for youth displaying aggression were 3.02 times (P < 0.001) more likely, with Clinical Global Impression-Severity > 4 were 2.36 times (P < 0.001) more likely, and prescribed antipsychotics were 4.30 times more likely to concern an ASD patient (P < 0.001). A larger proportion of ASD patients (vs. non-ASD) had comorbid psychiatric diagnoses of attention-deficit hyperactivity disorder, a learning disability, and disruptive behavior disorder vs. a smaller proportion with major depressive disorder. CONCLUSIONS: ASD patients for whom primary care providers sought Maryland's CPAP consultation were more severe and complex than non-ASD patients in terms of comorbid diagnoses and medication regimen.

Characteristics of Providers Using a Child Psychiatry Access Program.

OBJECTIVE: Child psychiatry access programs (CPAPs) help increase access to mental health services. This study aimed to provide information on the types of pediatric primary care clinicians (PPCCs) who call Maryland's CPAP. METHODS: Descriptive statistics and multinomial logistic regressions were conducted with data from 676 PPCCs who called Maryland's CPAP at least once between October 2012 and June 2019. RESULTS: On average, PPCCs contacted Maryland's CPAP 6.8 times. Providers who called seven or more times were more likely to have an allopathic or osteopathic medicine degree and to specialize in pediatrics. Providers calling from rural regions were less likely to call only for referrals. CONCLUSIONS: Most PPCCs contacted the CPAP for consultation or referrals but not both. PPCCs in rural areas were more likely to call for consultation, suggesting that they may be more likely to manage the care of patients with mental health conditions themselves, because of a lack of resources in their locations.

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.

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.

Telepsychotherapy with Youth at Clinical High Risk for Psychosis: Clinical Issues and Best Practices during the COVID-19 Pandemic.

Early detection and prevention of psychosis has become an international priority. Much of this work has focused on youth presenting with attenuated symptoms of psychosis-those at Clinical High Risk for psychosis (CHR)-given their elevated probability of developing the full disorder in subsequent years. Individuals at CHR may be prone to exacerbated psychological distress during the COVID-19 pandemic and its subsequent physical isolation measures, due to heightened stress sensitivity and comorbid mental health problems. Telepsychotherapy holds promise for reaching this population, especially during the current COVID-19 outbreak. However, there are limited evidence-based guidelines or interventions for use of telepsychotherapy with this population. In this paper, we review common clinical issues for individuals at CHR and how they might be exacerbated by the COVID-19 pandemic; best practices for treatment and adaptations for telepsychotherapy for individuals at CHR; and highlight real clinical issues that we are currently experiencing in a United States-based specialized CHR clinic as we conduct telepsychotherapy via videoconferencing. We conclude with questions for those in the field to contemplate, as well as potential challenges and benefits in using telepsychotherapy with individuals at CHR and their families.

Appetitive characteristics in children with cystic fibrosis: Questionnaire validation and associations with nutritional status.

BACKGROUND: Appetitive characteristics are an important factor in the nutritional status of children with cystic fibrosis (CF). We administered a brief parent-report eating behavior questionnaire, validated in healthy children, to determine the relationship between appetitive characteristics and body weight in children with CF. METHODS: Parents of children attending the Johns Hopkins Pediatric CF Clinic completed the Child Eating Behavior Questionnaire (CEBQ) at a routine clinic visit. Responses were correlated with anthropometric and other clinical data. RESULTS: Parents of 64 children with CF aged 7.74 ±â€¯3.17 years (mean ±â€¯SD) completed the CEBQ. The CEBQ subscales demonstrated good internal consistency (Cronbach's α = 0.76-0.94). Higher scores on food avoidance subscales (Slowness in Eating) were associated with lower body mass index (BMI) z-scores, and higher scores on food approach subscales (Food Responsiveness, Enjoyment of Food, Emotional Overeating) with higher BMI z-scores. Children with feeding aids (i.e. gastric tube or appetite-stimulating medications) demonstrated greater food avoidance (Slowness in Eating) and lesser food approach (Enjoyment of Food) when compared to those without feeding aids. Children with pancreatic insufficiency also demonstrated greater food avoidance (Slowness in Eating). CONCLUSIONS: The CEBQ can be used in a clinical setting to identify children with CF with appetitive characteristics associated with difficulty gaining weight. These children could potentially benefit from earlier interventions to aid in weight gain. Characterization of appetite using the CEBQ could aid investigation of the biological etiology of low appetite, and optimization of clinical and parental approaches to achieving a healthy nutritional status.

Associations of neuroticism-impulsivity and coping with binge eating in a nationally representative sample of adolescents in the United States.

OBJECTIVE: Binge eating behavior is a public health concern due to its negative physical and mental health consequences. Little is known about the interplay of personality traits, coping styles, and binge eating in the general adolescent population. We examined the associations among the combination of neuroticism and impulsivity (NI), maladaptive coping styles (poor problem solving, distraction, and escape-avoidance), and lifetime prevalence of binge eating in a nationally representative sample of U.S. adolescents. We also explored coping as a moderator of the NI-lifetime binge eating association and gender as a moderator of the NI-coping associations and coping-lifetime binge eating associations. METHODS: We used data from the National Comorbidity Survey: Adolescent Supplement (NCS-A: 2001-2004), a cross-sectional nationally representative study of adolescents aged 13 to 18years (n=10,028). We studied the associations of NI and coping with lifetime binge eating using multivariate regression models. RESULTS: High NI was significantly associated with all three coping styles, especially escape-avoidance (ß=3.96, confidence interval [CI]=3.62, 4.29, p<0.001). Gender was a significant moderator of the NI-distraction coping association (ß=-0.68, CI=-1.33, -0.03, p=0.041), indicating a stronger association in males (ß=1.20, CI=0.81, 1.58, p<0.001) than females (ß=0.53, CI=0.02, 1.03, p=0.042). Lifetime prevalence of binge eating was 1.13 times higher with increased escape-avoidance coping (CI=1.10, 1.18, p<0.001). DISCUSSION: Our findings indicate significant associations among high NI, increased escape-avoidance coping, and higher lifetime prevalence of binge eating in adolescents. Findings of our study have potential to inform development of interventions that target modification of maladaptive personality traits and coping styles to reduce problematic eating.

Gender and racial/ethnic differences in binge eating symptoms in a nationally representative sample of adolescents in the United States.

OBJECTIVE: Binge eating disorder (BED) is the most prevalent eating disorder in the U.S. adolescent population. Both BED and subthreshold binge eating disorder (SBED) are associated with physical and mental health problems. Gender and racial/ethnic differences in prevalence of binge eating in a nationally representative sample of adolescents have been reported but have not yet been assessed in relation to individual symptoms of binge eating. We examined gender and racial/ethnic differences in endorsement of eight binge eating symptoms in a nationally representative sample of U.S. adolescents. METHODS: We used data from the National Comorbidity Survey-Adolescent Supplement (NCS-A; 2001-2004), a nationally representative cross-sectional study of adolescents aged 13 to 18years (n=9336). We compared binge eating symptoms across gender and racial/ethnic groups using multivariable regression models. RESULTS: Females endorsed more binge eating symptoms than males associated with loss of control ('eat when not hungry') (adjusted prevalence ratio [aPR]=1.18, 95% confidence interval [CI]=1.02, 1.37, p=0.024) and distress (e.g., 'afraid of weight gain while binge eating' [aPR]=3.29, CI=2.43, 4.47, p<0.001). Racial/ethnic minorities displayed different patterns of binge eating symptoms than non-Hispanic Whites. Hispanics reported being more 'afraid of weight gain while binge eating' (aPR=2.05, CI=1.25, 3.37, p=0.006) than non-Hispanic Blacks. DISCUSSION: Our findings suggest significant gender and racial/ethnic differences in binge eating symptom presentation. Future work should explore reasons for these gender and racial/ethnic differences and consider these differences when determining how best to prevent and treat binge eating in adolescents.

Associations of Neuroticism and Impulsivity with Binge Eating in a Nationally Representative Sample of Adolescents in the United States.

Binge eating behavior is a public health concern with serious physical and mental health consequences. Certain personality traits have been found to contribute to the development of eating disorders in clinical samples of youth, but little is known about associations between personality traits and binge eating in the general adolescent population. We examined the associations of neuroticism and impulsivity-both independently and in combination-with lifetime prevalence of binge eating, using nationally representative, cross-sectional data from the National Comorbidity Survey: Adolescent Supplement (n=437). Neuroticism and impulsivity were each significantly associated with lifetime prevalence of binge eating (adjusted prevalence ratio [aPR]=1.11, confidence interval [CI]=1.07, 1.15, p<0.001; aPR=1.06, CI=1.04, 1.09, p<0.001, respectively). The combination of high neuroticism and high impulsivity was associated with higher lifetime binge eating than the combination of low neuroticism and low impulsivity (aPR=3.72, CI=2.45, 5.65, p<0.001), and this association was stronger for female than male adolescents (females: aPR=5.37, CI=3.24, 8.91, p<0.001 vs. males: aPR=2.45, CI=1.43, 4.22, p=0.002). Our findings have implications for informing theories of etiology and interventions to target binge eating behaviors.

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study.

OBJECTIVE: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. METHOD: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. RESULTS: CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%; p = .03) or VAL (35.0%; p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. CONCLUSION: Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome. Clinical trial registration information-Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM); http://clinicaltrials.gov; NCT00057681.

Overlapping neurobehavioral circuits in ADHD, obesity, and binge eating: evidence from neuroimaging research.

Attention-deficit/hyperactivity disorder (ADHD) and conditions involving excessive eating (eg, obesity, binge/loss of control eating) are increasingly prevalent within pediatric populations, and correlational and some longitudinal studies have suggested inter-relationships between these disorders. In addition, a number of common neural correlates are emerging across conditions, eg, functional abnormalities within circuits subserving reward processing and executive functioning. To explore this potential cross-condition overlap in neurobehavioral underpinnings, we selectively review relevant functional neuroimaging literature, specifically focusing on studies probing (i) reward processing, (ii) response inhibition, and (iii) emotional processing and regulation, and we outline 3 specific shared neurobehavioral circuits. Based on our review, we also identify gaps within the literature that would benefit from further research.

Decreased Escitalopram Concentrations Post-Roux-en-Y Gastric Bypass Surgery.

BACKGROUND: There is a high coincidence between obesity and psychiatric disorders including depression. Depressive disorders are commonly treated with antidepressants, including the selective serotonin reuptake inhibitor Lexapro (escitalopram). Although candidates for elective Roux-en-Y gastric bypass (RYGB) surgery may be treated with escitalopram, drug dosing strategies are typically not adjusted postoperatively. Therefore, studies are needed to better characterize escitalopram drug concentrations in a postsurgical setting. METHODS: Turbulent flow-liquid chromatographic-tandem mass spectrometric methods were used to quantify escitalopram concentrations in serum in study participants approved for RYGB. Blood was collected from study subjects 2 weeks before surgery, and 2 and 6 weeks postoperatively, to assess the impact of RYGB on systemic drug concentrations. RESULTS: Twelve samples from 4 study participants were collected and analyzed for serum escitalopram concentrations. Two weeks post-RYGB, although there were minimal changes in each participant's body mass index (<5%), drug concentrations were 33% (4%-71%) decreased as compared with presurgical serum concentrations. There were further decreases in drug concentrations 6 weeks postsurgery. All clinical laboratory values were within normal reference intervals. CONCLUSIONS: RYGB significantly alters the gastrointestinal tract and impacts escitalopram drug concentrations, even shortly after surgery.

Pediatric loss of control eating syndrome: Association with attention-deficit/hyperactivity disorder and impulsivity.

OBJECTIVE: Despite data linking Attention-deficit/Hyperactivity Disorder (ADHD) and adult binge eating, there are limited data in children with loss of control (LOC) eating. We examined inhibitory control in children with LOC eating syndrome (LOC-ES) and its association with ADHD. METHOD: 79 children (8-14 years) over the fifth weight percentile were recruited, irrespective of LOC eating or ADHD status. The Eating Disorder Examination for Children and the Standard Pediatric Eating Episode Interview assessed LOC-ES. ADHD diagnosis was determined by the Schedule for Affective Disorders and Schizophrenia for children and Conners-3 (Parent Report) DSM-IV Scales of Inattention and/or Hyperactivity (T score > 65). The Go/No-Go (GNG) Task and the Behavior Regulation Inventory of Executive Function (BRIEF) assessed impulse control. RESULTS: Odds of LOC-ES were increased 12 times for children with ADHD (adjusted odds ratio [aOR] = 12.68, 95% confidence interval [CI] = 3.11, 51.64, p < 0.001), after adjusting for BMI z scores and relevant covariates. Children had 1.17 times higher odds of reporting LOC-ES with every 5% increase in GNG Commission Rate (aOR = 1.17, CI = 1.01, 1.36, p < 0.05) and 1.25 times higher odds of reporting LOC-ES with every 5 unit T-score increase in BRIEF Inhibit Scale (aOR = 1.25, CI = 1.04, 1.50, p < 0.05). DISCUSSION: Children with ADHD had significantly greater odds of LOC-ES compared to children without ADHD. Children with LOC-ES had significantly greater impulse control deficits on performance-based neuropsychological assessments and on parent reports than children without LOC-ES. These findings suggest a need to investigate possible shared mechanisms such as impulse control deficits, among children with LOC-ES and ADHD.

Chewing and spitting: a marker of psychopathology and behavioral severity in inpatients with an eating disorder.

Chewing and spitting out food is a frequent behavior in hospitalized patients with eating disorders (ED). Personality characteristics of those who frequently chew-spit (CHSP), the amount of food consumed during CHSP episodes, associated sense of loss of control overeating (LOC), and clinical response to hospital-based treatment have not been examined and were the focus of this study. Participants (N=324) were inpatients on a behavioral ED specialty unit. A third of the sample (n=107) reported engaging in CHSP in the 8weeks prior to admission with 21% (n=69) reporting CHSP at least once per week. Those who engaged in the behavior at least weekly (CHSP+) were compared to those with less frequent or no CHSP (CHSP-) on demographic and clinical indices and on the EDI, BDI, and the NEO-FFI. Participants were also asked if their CHSP behavior involved a binge-like amount of food (≥1000kcal) or was associated with LOC. The CHSP+ group was more likely to have purging diagnoses. After controlling for purging diagnosis, CHSP+ were found to engage in more restricting, diet pill and laxative use, and excessive exercise, and endorsed greater drive for thinness, body dissatisfaction, depression, and neuroticism than CHSP-. Among all CHSP+ participants, LOC was present in 70% and a minority (n=10, 18%) endorsed recent CHSP on binge-like amounts of food. This behavior should be assessed routinely in all patients, as it appears associated with increased eating behavior severity and increased psychiatric comorbidity at hospital admission.

Are Eating Disorders Related to Attention Deficit/Hyperactivity Disorder?

Attention deficit/hyperactivity disorder (ADHD) is a disorder characterized by impulsivity, hyperactivity, and inattention. Binge-eating behavior is often impulsive and is the hallmark of the two eating disorders, binge-eating disorder (BED) and bulimia nervosa (BN), both of which are associated with significant health impairment. Bingeing behavior is also seen in the binge purge subtype of anorexia nervosa. Individuals with AN of the binge purge subtypes, BN and BED, have been found to exhibit impulsive behaviors that are often not limited to binge eating alone. There is preliminary evidence linking ADHD to BN and to BED in both adults and children. The neurobiological mechanisms behind these associations are only beginning to emerge; however, they suggest that impulse control deficits may play a role in these eating disorders. Additionally, although they may not meet full criteria for one of these eating disorders, some adults and children with ADHD present with dysregulated, impulsive eating disorder behaviors and there is a growing association between ADHD, obesity, and binge-eating behavior in both children and adults. The relationship between ADHD and binge eating is novel, supported by growing evidence and worthy of further research. We will review the underlying neurobiological underpinnings, neuroimaging data, and possible psychopharmacological treatment options, which target both ADHD and binge-eating behaviors as well as future research and treatment directions.

Association between binge eating and attention-deficit/hyperactivity disorder in two pediatric community mental health clinics.

OBJECTIVE: Attention-Deficit/ Hyperactivity Disorder (ADHD) has been linked with obesity; however its relationship with binge eating (BE) is less clear. We aimed to explore the associations among ADHD, weight, and BE in pediatric mental health clinics. METHOD: We retrospectively reviewed consecutive intakes in two pediatric mental health clinics (N = 252). BE was assessed using the C-BEDS scale. Associations between ADHD, BE, and BMI-z score were assessed via regression. RESULTS: Mean age was 10.8 (3.7 SD) years. Twelve percent (n = 31) had BE. The association between ADHD and BE was statistically significant (OR 16.1, p < .001), and persisted after adjusting for comorbid diagnoses, medications, demographic variables, and clinic. There was a statistically significant association between ADHD and BMI z-scores (ß = 0.54, p < .001). After adjusting for BE, the relationship between ADHD and BMI z-scores was attenuated (ß = 0.35, p = .025), and the coefficient for BE was decreased (ß = 0.75, p = .001). Although stimulant use was associated with a three-fold increase in odds of BE (OR 3.16, p = .006), stimulants were not associated with greater BMI-z scores (ß = 0.18, p = .32). DISCUSSION: There was a significant association between ADHD and BE in two pediatric mental health clinics. Although these data are cross-sectional, and cannot be used to make causal inferences, these findings are compatible with the hypothesis that BE partially mediates the association between ADHD and BMI z-scores. In mental health clinics, children with ADHD may present as overweight or obese. Further, children with ADHD may exhibit BE. Future prospective studies should elucidate the complex relationships among ADHD, weight, stimulants, and BE.

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

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.

Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents.

OBJECTIVE: The aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels. METHODS: Data from the Research Units on Pediatric Psychopharmacology (RUPP) Anxiety Study were examined for 45 youths (22 active fluvoxamine, 23 placebo) treated for Diagnostic and Statistical Manual for Mental Disorders, 4(th) edition (DSM-IV) anxiety disorders at the Johns Hopkins University site with an 8-week forced-flexible titration schedule. As part of the double-blind placebo-controlled trial, AC-AEs were recorded by clinicians at weekly patient visits. AC-AEs were defined as hyperactivity, activation, and disinhibition. Demographic characteristics, daily doses, and week-8 blood levels were examined in relation to the presence of AC-AEs. The prevalence of AC-AE and time to first event were established for those who experienced this side effect. RESULTS: AC-AEs were found in 10 of 22 participants (45%) receiving fluvoxamine and only 1 of 23 in the placebo group (4%). The onset of AC-AEs occurred from week 1 to week 8, with the majority occurring at or before week 4. The mean fluvoxamine blood level at week 8 in subjects with AC-AEs was higher than in subjects without AC-AEs (n = 16, t = -2.61, p = 0.04). Neither the age of the participants nor family history of bipolar or anxiety disorder differed between those who did and did not develop an AC-AE. CONCLUSIONS: AC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.