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McElroy S.L.,University of Cincinnati | Hudson J.,Biological Psychiatry Laboratory | Hudson J.,Harvard University | Ferreira-Cornwell M.C.,Shire Inc | And 3 more authors.
Neuropsychopharmacology | Year: 2016

The efficacy and safety of lisdexamfetamine dimesylate (LDX) vs placebo in binge eating disorder (BED) was evaluated in two multicenter, double-blind, placebo-controlled trials. Adults (study 1, n=383; study 2, n=390) meeting DSM-IV-TR BED criteria were randomized (1:1) to placebo or LDX (50 or 70 mg/day) dose titration; optimized doses were maintained to the end of double-blind treatment (week 12/early termination). Change from baseline in binge eating days/week at weeks 11-12 (primary efficacy endpoint) was assessed with mixed-effects models for repeated measures. Secondary endpoints related to binge eating and medical parameters, safety, and treatment compliance were also assessed. Least squares mean (95% CI) treatment differences for change from baseline binge eating days/week at weeks 11-12 significantly favored LDX (study 1:-1.35 [-1.70,-1.01]; study 2:-1.66 [-2.04,-1.28]; both P<0.001). In both studies, treatment-emergent adverse events (TEAEs) reported by ≥10% of LDX participants were dry mouth, insomnia, and headache. Serious TEAEs occurred in two (1.1%) placebo participants in each study and in three (1.6%) and one (0.6%) LDX participants in study 1 and study 2, respectively. Across studies, mean increases from baseline at week 12/early termination with LDX for pulse and systolic and diastolic blood pressure ranged from 4.41-6.31 b.p.m. and 0.2-1.45 and 1.06-1.83 mm Hg, respectively. LDX (50 and 70 mg/day) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating-related key secondary endpoints. Safety results appear consistent with the known safety profile of LDX. © 2015 of the American College of Neuropsychopharmacology. Source


Javaras K.N.,University of Wisconsin - Madison | Hudson J.I.,Harvard University | Hudson J.I.,Biological Psychiatry Laboratory | Laird N.M.,Harvard University
Genetic Epidemiology | Year: 2010

Investigators interested in whether a disease aggregates in families often collect case-control family data, which consist of disease status and covariate information for members of families selected via case or control probands. Here, we focus on the use of case-control family data to investigate the relative contributions to the disease of additive genetic effects (A), shared family environment (C), and unique environment (E). We describe an ACE model for binary family data; this structural equation model, which has been described previously, combines a general-family extension of the classic ACE twin model with a (possibly covariate-specific) liability-threshold model for binary outcomes. We then introduce our contribution, a likelihood-based approach to fitting the model to singly ascertained case-control family data. The approach, which involves conditioning on the proband's disease status and also setting prevalence equal to a prespecified value that can be estimated from the data, makes it possible to obtain valid estimates of the A, C, and E variance components from case-control (rather than only from population-based) family data. In fact, simulation experiments suggest that our approach to fitting yields approximately unbiased estimates of the A, C, and E variance components, provided that certain commonly made assumptions hold. Further, when our approach is used to fit the ACE model to Austrian case-control family data on depression, the resulting estimate of heritability is very similar to those from previous analyses of twin data. © 2009 Wiley-Liss, Inc. Source


Halpern J.H.,Laboratory for Integrative Psychiatry | Sherwood A.R.,McLean Hospital | Sherwood A.R.,Harvard University | Sherwood A.R.,University of New Mexico | And 4 more authors.
Addiction | Year: 2011

Aims In field studies assessing cognitive function in illicit ecstasy users, there are several frequent confounding factors that might plausibly bias the findings toward an overestimate of ecstasy-induced neurocognitive toxicity. We designed an investigation seeking to minimize these possible sources of bias. Design We compared illicit ecstasy users and non-users while (1) excluding individuals with significant life-time exposure to other illicit drugs or alcohol; (2) requiring that all participants be members of the 'rave' subculture; and (3) testing all participants with breath, urine and hair samples at the time of evaluation to exclude possible surreptitious substance use. We compared groups with adjustment for age, gender, race/ethnicity, family-of-origin variables and childhood history of conduct disorder and attention deficit hyperactivity disorder. We provide significance levels without correction for multiple comparisons. Setting Field study. Participants Fifty-two illicit ecstasy users and 59 non-users, aged 18-45 years. Measurements Battery of 15 neuropsychological tests tapping a range of cognitive functions. Findings We found little evidence of decreased cognitive performance in ecstasy users, save for poorer strategic self-regulation, possibly reflecting increased impulsivity. However, this finding might have reflected a pre-morbid attribute of ecstasy users, rather than a residual neurotoxic effect of the drug. Conclusions In a study designed to minimize limitations found in many prior investigations, we failed to demonstrate marked residual cognitive effects in ecstasy users. This finding contrasts with many previous findings-including our own-and emphasizes the need for continued caution in interpreting field studies of cognitive function in illicit ecstasy users. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction. Source


Kanayama G.,Biological Psychiatry Laboratory | Kanayama G.,Harvard University | Pope H.G.,Biological Psychiatry Laboratory | Pope H.G.,Harvard University
Current Opinion in Endocrinology, Diabetes and Obesity | Year: 2012

Purpose of Review: To summarize recent advances in studies of illicit use of androgens and other hormones. Recent Findings: Androgens and other appearance-enhancing and performance-enhancing substances are widely abused worldwide. Three notable clusters of findings have emerged in this field in recent years. First, studies almost unanimously find that androgen users engage in polypharmacy, often ingesting other hormones (e.g., human growth hormone, thyroid hormones, and insulin), ergo/thermogenic drugs (e.g., caffeine, ephedrine, and clenbuterol), and classical drugs of abuse (e.g., cannabis, opiates, and cocaine). Second, reports of long-term psychiatric and medical adverse effects of androgens continue to accumulate. In cardiovascular research particularly, controlled studies have begun to supersede anecdotal evidence, strengthening the case that androgens (possibly acting synergistically with other abused drugs) may cause significant morbidity and even mortality. Third, it is increasingly recognized that androgen use may lead to a dependence syndrome with both psychological and physiological origins. Androgen dependence likely affects some millions of individuals worldwide, and arguably represents the least studied major class of illicit drug dependence. Summary: Given mounting evidence of the adverse effects of androgens and associated polypharmacy, this topic will likely represent an expanding area of research and an issue of growing public health concern. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins. Source


Hudson J.I.,Harvard University | Hudson J.I.,Biological Psychiatry Laboratory | Coit C.E.,Harvard University | Coit C.E.,Biological Psychiatry Laboratory | And 2 more authors.
International Journal of Eating Disorders | Year: 2012

Objective: To estimate how much the prevalence of binge eating disorder will increase under the new proposed DSM-5 criteria, which relax the requirements for the frequency and duration of eating binges. Method: Interview data from a nonclinical sample of 888 first-degree relatives who had participated in a family study of binge eating disorder were analyzed. The probands in this study (not included in this analysis) had been selected to either have binge eating disorder or no history of eating binges. Results: The increase in the prevalence of binge eating disorder using the proposed DSM-5 criteria relative to the DSM-IV criteria was 2.9% in women and 3.0% men for lifetime prevalence, and 7.7% in women and 0% in men for the point prevalence. Discussion: Changes in frequency and duration of binge episodes proposed for DSM-5 will likely have only a minimal effect on the prevalence of binge eating disorder. © 2011 Wiley Periodicals, Inc. Source

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