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Susan L Mcelroy - One of the best experts on this subject based on the ideXlab platform.
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assessment of amphetamine withdrawal symptoms of Lisdexamfetamine dimesylate treatment for adults with binge eating disorder
The Primary Care Companion To The Journal of Clinical Psychiatry, 2020Co-Authors: Brigitte Robertson, James Wu, Reginald V Fant, Sidney H Schnoll, Susan L McelroyAbstract:Objective To determine whether physical dependence developed during Lisdexamfetamine dimesylate treatment, as evidenced by presence of withdrawal symptoms after treatment cessation in adults with binge-eating disorder (BED) treated for up to 38 weeks. Methods Three studies enrolled adults with DSM-IV-TR-defined BED. In two 12-week, randomized, double-blind, placebo-controlled studies conducted from November 2012 to September 2013, participants were treated with placebo or dose-optimized Lisdexamfetamine (50 or 70 mg). In a double-blind, placebo-controlled, randomized-withdrawal maintenance-of-efficacy study conducted from January 2014 to April 2015, participants categorized as responders after 12 weeks of open-label Lisdexamfetamine (50 or 70 mg) were randomized to continued Lisdexamfetamine or placebo for 26 weeks. The Amphetamine Cessation Symptom Assessment (ACSA), a 16-item self-report instrument (total score: 0-64), assessed withdrawal experiences. Mean ± SD ACSA scores and medians are presented for study completers. Results In the short-term efficacy studies, mean ± SD ACSA aggregate scores for placebo and Lisdexamfetamine (pooled data) were 7.0 ± 7.60 (n = 275) and 4.9 ± 6.41 (n = 271), respectively, on the day of the last dose at week 12/early termination (ET) and 4.8 ± 6.82 (n = 234) and 5.5 ± 7.50 (n = 221) on day 7 after the last dose. In the maintenance-of-efficacy study, mean ± SD ACSA aggregate scores for placebo and Lisdexamfetamine were 4.8 ± 6.67 (n = 44) and 4.7 ± 7.78 (n = 85) on the day of the last dose at week 38/ET and 3.9 ± 5.75 (n = 37) and 5.2 ± 7.93 (n = 71) on day 7 after the last dose. Conclusions Study results suggest that abrupt Lisdexamfetamine termination was not associated with amphetamine withdrawal symptoms at the exposure durations and therapeutic doses analyzed. Trial registration Clinicaltrials.gov identifiers: NCT01718483, NCT01718509, and NCT02009163.
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Lisdexamfetamine in pediatric binge eating disorder a retrospective chart review
Clinical Neuropharmacology, 2019Co-Authors: Anna I Guerdjikova, Thomas J Blom, Nicole Mori, Abigail Matthews, Tracy Cummings, Leah L Casuto, Susan L McelroyAbstract:Objectives The purpose of this retrospective chart review was to evaluate Lisdexamfetamine dimesylate (LDX) in the treatment of pediatric binge eating disorder (BED). Methods We examined the clinical records of 25 patients, 12 to 19 years of age, who were prescribed LDX and had a diagnosis of BED between 2014 and 2017. Results Binge eating disorder in adolescents was highly comorbid with attention deficit hyperactivity disorder, mood and anxiety disorders, and severe obesity. Fifteen participants reported some level of improvement of their BED symptoms with LDX treatment. Posttreatment body mass index (BMI) percentile was not significantly reduced, and all but 2 participants remained in their same BMI classification. Lisdexamfetamine dimesylate treatment duration was not associated with change in BMI percentile, and the medication was well tolerated. Conclusions Lisdexamfetamine dimesylate may have clinical utility for BED in adolescents, but randomized, placebo-controlled studies of its efficacy, tolerability, and safety in this population are needed.
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efficacy of Lisdexamfetamine in adults with moderate to severe binge eating disorder a randomized clinical trial
JAMA Psychiatry, 2017Co-Authors: James I Hudson, Celeste M Ferreiracornwell, Susan L Mcelroy, Jana Radewonuk, Maria GasiorAbstract:Importance The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective To assess Lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults metDSM-IV-Rbinge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [Lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), Lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued Lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Interventions Lisdexamfetamine administration. Main Outcomes and Measures The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Results Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized Lisdexamfetamine responders (placebo, n = 138; Lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for Lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37;P Conclusions and Relevance Risk of binge-eating relapse over 6 months was lower in participants continuing Lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with Lisdexamfetamine than placebo. Trial Registration clinicaltrials.gov Identifier:NCT02009163
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a phase 3 multicenter open label 12 month extension safety and tolerability trial of Lisdexamfetamine dimesylate in adults with binge eating disorder
Journal of Clinical Psychopharmacology, 2017Co-Authors: Maria Gasior, Celeste M Ferreiracornwell, James I Hudson, Jana Radewonuk, Javier Quintero, Susan L McelroyAbstract:AbstractBackgroundA 12-month, open-label extension study assessed the long-term safety and tolerability of Lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED).MethodsAdults (aged 18–55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label
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novel pharmacologic treatment in acute binge eating disorder role of Lisdexamfetamine
Neuropsychiatric Disease and Treatment, 2016Co-Authors: Anna I Guerdjikova, Nicole Mori, Leah L Casuto, Susan L McelroyAbstract:Binge eating disorder (BED) is the most common eating disorder and an important public health problem. It is characterized by recurrent episodes of excessive food consumption accompanied by a sense of loss of control over the binge eating behavior without the inappropriate compensatory weight loss behaviors of bulimia nervosa. BED affects both sexes and all age groups and is associated with medical and psychiatric comorbidities. Until recently, self-help and psychotherapy were the primary treatment options for patients with BED. In early 2015, Lisdexamfetamine dimesylate, a prodrug stimulant marketed for attention deficit hyperactive disorder, was the first pharmacologic agent to be approved by the US Food and Drug Administration for the treatment of moderate or severe BED in adults. This article summarizes BED clinical presentation, and discusses the pharmacokinetic profile, efficacy, and safety of Lisdexamfetamine dimesylate in the treatment of BED in adults.
Richard H Weisler - One of the best experts on this subject based on the ideXlab platform.
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Attention deficit hyperactivity disorder subtypes and symptom response in adults treated with Lisdexamfetamine dimesylate.
Innovations in clinical neuroscience, 2020Co-Authors: Greg Mattingly, Richard H Weisler, Bryan Dirks, Thomas Babcock, Ben Adeyi, Brian Scheckner, Robert LasserAbstract:To evaluate the efficacy of Lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder symptom subtypes who exhibit predominantly inattention, hyperactivity/ impulsivity, or combined symptom clusters. This is a post-hoc analysis from a multicenter, one-year, open-label Lisdexamfetamine dimesylate study in adults with attention deficit hyperactivity disorder previously completing two weeks or more in a four-week, randomized, placebo-controlled Lisdexamfetamine dimesylate study, using Attention Deficit Hyperactivity Disorder Rating Scale IV symptom ratings as an attention deficit hyperactivity disorder subtype proxy (N=349). Attention Deficit Hyperactivity Disorder Rating Scale IV was measured at baseline of prior study and throughout the open-label study. Proxy subtypes were based on item scores of 2 (moderate) or 3 (severe), representing endorsement of at least six of nine symptoms on respective subscales; predominantly combined type endorsed at least six of nine symptoms on each subscale. Overall safety evaluations included treatment-emergent adverse events. At baseline, 93 of 345 participants exhibited predominantly inattention, 13 predominantly hyperactivity/ impulsivity, 236 combined symptom clusters, and three were unassigned. For the three subgroups, respectively, mean (standard deviation) Attention Deficit Hyperactivity Disorder Rating Scale IV total scores at baseline were 34.5 (4.02), 33.8 (3.27), and 43.6 (5.24); change from baseline to endpoint scores were -19.3 (9.48), -24.0 (7.22), and -27.3 (11.78). Mean (standard deviation) end-of-study Lisdexamfetamine dimesylate dose was 57.7 (14.75), 53.1 (16.01), and 56.9 (14.94)mg/day, respectively.Treatment-emergent adverse events (>5%) were upper respiratory tract infection (21.8%), insomnia (19.5%), headache (17.2%), dry mouth (16.6%), decreased appetite (14.3%), irritability (11.2%), anxiety (8.3%), nasopharyngitis (7.4%), sinusitis (6.6%), decreased weight (6.0%), back pain (5.4%), and muscle spasms (5.2%). Lisdexamfetamine dimesylate was effective in participants with predominantly inattention, hyperactivity/ impulsivity, and combined attention deficit hyperactivity disorder symptom clusters. Groups exhibiting specific predominant subtype symptoms did not differ in clinical response to Lisdexamfetamine dimesylate.
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self reported quality of life in adults with attention deficit hyperactivity disorder and executive function impairment treated with Lisdexamfetamine dimesylate a randomized double blind multicenter placebo controlled parallel group study
BMC Psychiatry, 2013Co-Authors: Lenard A Adler, Richard H Weisler, Bryan Dirks, Patrick Deas, Aparna Raychaudhuri, Matthew Dauphin, Keith E SaylorAbstract:Background This study examined the effects of Lisdexamfetamine dimesylate (LDX) on quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) and clinically significant executive function deficits (EFD).
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Lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder who report clinically significant impairment in executive function results from a randomized double blind placebo controlled study
The Journal of Clinical Psychiatry, 2013Co-Authors: Lenard A Adler, Bryan Dirks, Patrick Deas, Aparna Raychaudhuri, Matthew Dauphin, Robert A Lasser, Richard H WeislerAbstract:OBJECTIVE: Behavioral rating scales that assess impairments in executive function commonly associated with attention-deficit/hyperactivity disorder (ADHD) may offer advantages over neuropsychological testing. The primary objective of this study was to evaluate the efficacy of Lisdexamfetamine dimesylate for executive function deficits in adults with ADHD and clinically significant executive function impairment using self-reported Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) assessments. METHOD: This randomized double-blind study, conducted between May 2010 and November 2010, screened at least 1 participant at 35 of 39 registered US clinical research sites. Adults (aged 18-55 years) with a primary ADHD diagnosis (meeting full DSM-IV-TR criteria) and executive function deficits (assessed by baseline BRIEF-A Global Executive Composite [GEC] T-scores of at least 65) were randomized to treatment with optimized Lisdexamfetamine dimesylate (30 mg/d, 50 mg/d, or 70 mg/d; n = 80) or placebo (n = 81) during a 10-week double-blind treatment period. Outcome measures included the BRIEF-A scales (GEC, index, and clinical subscales). RESULTS: At week 10 or at early termination, Lisdexamfetamine dimesylate was associated with significantly greater reductions from baseline in mean BRIEF-A GEC T-scores than placebo (effect size, 0.74; P < .0001) and significantly greater reductions from baseline in mean T-scores for both BRIEF-A index scales (Behavioral Regulation Index and Metacognition Index) and all 9 clinical subscales (P ≤ .0056 for all). At week 10 or at early termination, mean T-scores for BRIEF-A indexes and clinical subscales were below levels of clinically significant executive function deficits (ie, < 65) with Lisdexamfetamine dimesylate treatment. The mean (SD) GEC T-score was 57.2 (14.11) for the Lisdexamfetamine dimesylate group and 68.3 (17.12) for the placebo group. The safety profile of Lisdexamfetamine dimesylate was consistent with other long-acting psychostimulants. CONCLUSION: Among adults with ADHD and clinically significant executive function deficits, Lisdexamfetamine dimesylate was associated with significant improvements in self-reported executive function ratings. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01101022.
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maintenance of efficacy of Lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder randomized withdrawal design
The Journal of Clinical Psychiatry, 2012Co-Authors: Matthew Brams, Richard H Weisler, Robert L Findling, Maria Gasior, Mohamed Hamdani, Celeste M Ferreiracornwell, Liza SquiresAbstract:OBJECTIVE: To evaluate Lisdexamfetamine dimesylate maintenance of efficacy in adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Adults (aged 18-55 years) who had ADHD meeting DSM-IV-TR criteria, baseline ADHD Rating Scale-IV (ADHD-RS-IV) with adult prompts total scores of < 22, and Clinical Global Impressions-Severity of Illness (CGI-S) ratings of 1, 2, or 3 were enrolled. After previously receiving commercially available Lisdexamfetamine dimesylate (30, 50, or 70 mg/d) for ≥ 6 months with acceptable tolerability and maintaining response during a 3-week open-label phase at a stable Lisdexamfetamine dimesylate dose, the participants entered a 6-week double-blind randomized withdrawal phase on treatment with Lisdexamfetamine dimesylate (same dose) or placebo. Data were collected from April 2009 to July 2010. The primary outcome was the proportion of participants having symptom relapse (≥ 50% increase in ADHD-RS-IV score and ≥ 2 rating-point increase in CGI-S score). RESULTS: A total of 116 participants were randomized (Lisdexamfetamine dimesylate n = 56; placebo n = 60). At the randomized withdrawal phase baseline, mean (SD) ADHD-RS-IV scores for Lisdexamfetamine dimesylate and placebo were 10.6 (4.96) and 10.6 (4.82), respectively. At endpoint, 8.9% (5/56) of adults taking Lisdexamfetamine dimesylate and 75.0% (45/60) taking placebo (P < .0001) showed symptom relapse; most showed relapse after 1 and 2 weeks of the randomized withdrawal phase (4 and 0 adults taking Lisdexamfetamine dimesylate, 26 and 10 taking placebo, respectively). During the randomized withdrawal phase, treatment-emergent adverse events were reported in 48.2% and 30.0% of participants in the Lisdexamfetamine dimesylate and placebo groups, respectively. Treatment-emergent adverse events with incidence ≥ 5% in the Lisdexamfetamine dimesylate and placebo groups were headache (14.3% and 5.0%), insomnia (5.4% and 5.0%), and upper respiratory tract infection (8.9% and 0%). CONCLUSIONS: In adults with ADHD on medium- to long-term treatment, Lisdexamfetamine dimesylate demonstrated maintenance of efficacy vs placebo upon randomized withdrawal. A majority of patients given placebo showed symptom relapse by 2 weeks. The safety profile of Lisdexamfetamine dimesylate was generally consistent with previous Lisdexamfetamine dimesylate studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00877487.
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Maintenance of Efficacy of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Withdrawal Design
The Journal of Clinical Psychiatry, 2012Co-Authors: Matthew Brams, Richard H Weisler, Robert L Findling, Maria Gasior, Mohamed Hamdani, M. Celeste Ferreira-cornwell, Liza A. SquiresAbstract:OBJECTIVE: To evaluate Lisdexamfetamine dimesylate maintenance of efficacy in adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Adults (aged 18-55 years) who had ADHD meeting DSM-IV-TR criteria, baseline ADHD Rating Scale-IV (ADHD-RS-IV) with adult prompts total scores of < 22, and Clinical Global Impressions-Severity of Illness (CGI-S) ratings of 1, 2, or 3 were enrolled. After previously receiving commercially available Lisdexamfetamine dimesylate (30, 50, or 70 mg/d) for ≥ 6 months with acceptable tolerability and maintaining response during a 3-week open-label phase at a stable Lisdexamfetamine dimesylate dose, the participants entered a 6-week double-blind randomized withdrawal phase on treatment with Lisdexamfetamine dimesylate (same dose) or placebo. Data were collected from April 2009 to July 2010. The primary outcome was the proportion of participants having symptom relapse (≥ 50% increase in ADHD-RS-IV score and ≥ 2 rating-point increase in CGI-S score). RESULTS: A total of 116 participants were randomized (Lisdexamfetamine dimesylate n = 56; placebo n = 60). At the randomized withdrawal phase baseline, mean (SD) ADHD-RS-IV scores for Lisdexamfetamine dimesylate and placebo were 10.6 (4.96) and 10.6 (4.82), respectively. At endpoint, 8.9% (5/56) of adults taking Lisdexamfetamine dimesylate and 75.0% (45/60) taking placebo (P < .0001) showed symptom relapse; most showed relapse after 1 and 2 weeks of the randomized withdrawal phase (4 and 0 adults taking Lisdexamfetamine dimesylate, 26 and 10 taking placebo, respectively). During the randomized withdrawal phase, treatment-emergent adverse events were reported in 48.2% and 30.0% of participants in the Lisdexamfetamine dimesylate and placebo groups, respectively. Treatment-emergent adverse events with incidence ≥ 5% in the Lisdexamfetamine dimesylate and placebo groups were headache (14.3% and 5.0%), insomnia (5.4% and 5.0%), and upper respiratory tract infection (8.9% and 0%). CONCLUSIONS: In adults with ADHD on medium- to long-term treatment, Lisdexamfetamine dimesylate demonstrated maintenance of efficacy vs placebo upon randomized withdrawal. A majority of patients given placebo showed symptom relapse by 2 weeks. The safety profile of Lisdexamfetamine dimesylate was generally consistent with previous Lisdexamfetamine dimesylate studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00877487.
Lenard A Adler - One of the best experts on this subject based on the ideXlab platform.
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Lisdexamfetamine targets amygdala mechanisms that bias cognitive control in attention deficit hyperactivity disorder
Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, 2018Co-Authors: Kurt P Schulz, Lenard A Adler, Beth Krone, Anneclaude V Bedard, Stephanie Duhoux, Juan Pedraza, Sanweda Mahagabin, Jeffrey H NewcornAbstract:Abstract Background Prefrontal-limbic circuits that form the neural architecture for emotion to influence behavior have been implicated in the pathophysiology of attention-deficit/hyperactivity disorder (ADHD) and represent a potentially important target of medication treatment that has not been substantively evaluated. This study tested the effect of the psychostimulant prodrug Lisdexamfetamine dimesylate on amygdala activation and connectivity during the emotional bias of response execution and inhibition. Methods Twenty-five adults with ADHD were scanned twice with event-related functional magnetic resonance imaging while performing an emotional go/no-go task after 3 to 4 weeks of Lisdexamfetamine treatment and 3 weeks off medication in a randomized, counterbalanced, hybrid crossover design. Drug, trial type, and face emotion (happy, sad, or neutral) were included as within-subjects factors in repeated measures analyses of activation and connectivity. Results Lisdexamfetamine was associated with increased right amygdala activation and reduced psychophysiological interactions with the orbital aspect of the left inferior frontal gyrus specifically for responses to sad faces compared with placebo, but there was no effect on the accuracy of response execution or inhibition. The relative gain in right amygdala activation in response to sad faces for Lisdexamfetamine was correlated with a reduction in symptoms of ADHD. Conclusions Treatment with Lisdexamfetamine potentiates affective encoding in amygdala, purportedly via catecholaminergic mechanisms, but functionally disconnects the amygdala from inferior frontal regions that encode behavioral significance—resulting in reduced emotional bias of cognitive control. Pinpointing the neurophysiologic underpinnings of therapeutic improvement with Lisdexamfetamine represents a first step in developing targeted approaches to treatment of ADHD.
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Lisdexamfetamine Targets Amygdala Mechanisms That Bias Cognitive Control in Attention-Deficit/Hyperactivity Disorder
Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, 2018Co-Authors: Kurt P Schulz, Lenard A Adler, Beth Krone, Anneclaude V Bedard, Stephanie Duhoux, Juan Pedraza, Sanweda Mahagabin, Jeffrey H NewcornAbstract:Abstract Background Prefrontal-limbic circuits that form the neural architecture for emotion to influence behavior have been implicated in the pathophysiology of attention-deficit/hyperactivity disorder (ADHD) and represent a potentially important target of medication treatment that has not been substantively evaluated. This study tested the effect of the psychostimulant prodrug Lisdexamfetamine dimesylate on amygdala activation and connectivity during the emotional bias of response execution and inhibition. Methods Twenty-five adults with ADHD were scanned twice with event-related functional magnetic resonance imaging while performing an emotional go/no-go task after 3 to 4 weeks of Lisdexamfetamine treatment and 3 weeks off medication in a randomized, counterbalanced, hybrid crossover design. Drug, trial type, and face emotion (happy, sad, or neutral) were included as within-subjects factors in repeated measures analyses of activation and connectivity. Results Lisdexamfetamine was associated with increased right amygdala activation and reduced psychophysiological interactions with the orbital aspect of the left inferior frontal gyrus specifically for responses to sad faces compared with placebo, but there was no effect on the accuracy of response execution or inhibition. The relative gain in right amygdala activation in response to sad faces for Lisdexamfetamine was correlated with a reduction in symptoms of ADHD. Conclusions Treatment with Lisdexamfetamine potentiates affective encoding in amygdala, purportedly via catecholaminergic mechanisms, but functionally disconnects the amygdala from inferior frontal regions that encode behavioral significance—resulting in reduced emotional bias of cognitive control. Pinpointing the neurophysiologic underpinnings of therapeutic improvement with Lisdexamfetamine represents a first step in developing targeted approaches to treatment of ADHD.
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effectiveness and duration of effect of open label Lisdexamfetamine dimesylate in adults with adhd
Journal of Attention Disorders, 2017Co-Authors: Lenard A Adler, Lauren R Lynch, David M Shaw, Samantha P Wallace, Katherine E Odonnell, Michael A Ciranni, Alexis M Briggie, Stephen V FaraoneAbstract:Objectives: (a) Evaluate the efficacy and duration of effect of Lisdexamfetamine dimesylate (LDX) in adult ADHD. (b) Assess the reliability and validity of the Adult ADHD Medication Smoothness of E...
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clinical effects of Lisdexamfetamine and mixed amphetamine salts immediate release in adult adhd results of a crossover design clinical trial
Postgraduate Medicine, 2014Co-Authors: Lenard A Adler, Samuel Alperin, Terry L Leon, Stephen V FaraoneAbstract:AbstractObjectives: To examine the clinical effects of equivalent doses of single-blind (SB; patient-blind) Lisdexamfetamine (LDX) and mixed amphetamine salts-immediate release (MAS-IR) on adult attention-deficit/hyperactivity disorder (ADHD) in a placebo (PBO)-controlled, crossover design. Methods: Twenty-four subjects were treated sequentially in a fixed order with (1) SB PBO (matching LDX) for 1 week, (2) SB LDX (up to 70 mg/day) for 5 weeks, (3) SB PBO washout for 3 weeks, and (4) open-label treatment MAS-IR (tid up to 45 mg/day) for 5 weeks. Clinical effects on ADHD and executive function were assessed weekly throughout the trial with the ADHD Rating Scale with adult prompts, the Clinical Global Impression Severity Scale (CGI-S), and the Behavior Rating Inventory of Executive Function (BRIEF). Results: Lisdexamfetamine and MAS-IR were generally well tolerated. Significant and equal reductions on ADHD clinician ratings were seen. Significantly greater reductions in CGI-S and selected BRIEF subsets wer...
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self reported quality of life in adults with attention deficit hyperactivity disorder and executive function impairment treated with Lisdexamfetamine dimesylate a randomized double blind multicenter placebo controlled parallel group study
BMC Psychiatry, 2013Co-Authors: Lenard A Adler, Richard H Weisler, Bryan Dirks, Patrick Deas, Aparna Raychaudhuri, Matthew Dauphin, Keith E SaylorAbstract:Background This study examined the effects of Lisdexamfetamine dimesylate (LDX) on quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) and clinically significant executive function deficits (EFD).
Maria Gasior - One of the best experts on this subject based on the ideXlab platform.
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efficacy of Lisdexamfetamine in adults with moderate to severe binge eating disorder a randomized clinical trial
JAMA Psychiatry, 2017Co-Authors: James I Hudson, Celeste M Ferreiracornwell, Susan L Mcelroy, Jana Radewonuk, Maria GasiorAbstract:Importance The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective To assess Lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults metDSM-IV-Rbinge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [Lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), Lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued Lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Interventions Lisdexamfetamine administration. Main Outcomes and Measures The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Results Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized Lisdexamfetamine responders (placebo, n = 138; Lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for Lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37;P Conclusions and Relevance Risk of binge-eating relapse over 6 months was lower in participants continuing Lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with Lisdexamfetamine than placebo. Trial Registration clinicaltrials.gov Identifier:NCT02009163
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a phase 3 multicenter open label 12 month extension safety and tolerability trial of Lisdexamfetamine dimesylate in adults with binge eating disorder
Journal of Clinical Psychopharmacology, 2017Co-Authors: Maria Gasior, Celeste M Ferreiracornwell, James I Hudson, Jana Radewonuk, Javier Quintero, Susan L McelroyAbstract:AbstractBackgroundA 12-month, open-label extension study assessed the long-term safety and tolerability of Lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED).MethodsAdults (aged 18–55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label
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Maintenance of wakefulness with Lisdexamfetamine dimesylate, compared with placebo and armodafinil in healthy adult males undergoing acute sleep loss.
Journal of Clinical Psychopharmacology, 2014Co-Authors: Maria Gasior, Jon Freeman, Gary Zammit, Patricia Donnelly, Maria Celeste Ferreira-cornwell, Thomas RothAbstract:This study evaluated daytime alertness and performance with Lisdexamfetamine dimesylate during acute sleep loss. In a randomized, double-blind study in healthy adult men (n = 135) undergoing 24-hour sleep loss, the alerting effects of single oral Lisdexamfetamine dimesylate doses (20, 50, or 70 mg) were compared with a placebo and an active control (armodafinil 250 mg). Primary end point was mean unequivocal sleep latency on the 30-minute maintenance of wakefulness test taken every 2 hours from midnight to 8:00 A.M. Secondary end points included the Karolinska sleepiness scale and psychomotor vigilance task. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs. Least squares mean (SE) maintenance of wakefulness test unequivocal sleep latency (in minutes) was longer with Lisdexamfetamine dimesylate 20, 50, and 70 mg, or armodafinil 250 mg (23.3 [1.10], 27.9 [0.64], 29.3 [0.44], or 27.6 [0.63], respectively) versus placebo (15.3 [1.00]; P Language: en
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A generalized estimating equation approach to analysis of maintenance of wakefulness testing in a study of Lisdexamfetamine dimesylate, armodafinil, and placebo in sleep-deprived adults.
Journal of Clinical Psychopharmacology, 2014Co-Authors: Thomas Roth, M. Celeste Ferreira-cornwell, Jon Freeman, Gary Zammit, Patricia Donnelly, Maria GasiorAbstract:: In a study of acute sleep deprivation in healthy male volunteers randomized to double-blind treatment with Lisdexamfetamine dimesylate (20, 50, or 70 mg), placebo control, or an active control (armodafinil 250 mg), Maintenance of Wakefulness Test data were compared using a generalized estimating equation analysis to eliminate the need for unequivocal sleep latency imputation. Compared with placebo across all Maintenance of Wakefulness Tests, all active treatments were associated with lower risk of falling asleep (risk ratio [95% confidence interval]): 0.45 (0.27-0.76; P = 0.0026), 0.10 (0.05-0.20; P < 0.0001), and 0.05 (0.02-0.14; P < 0.0001) for 20, 50, and 70 mg Lisdexamfetamine dimesylate, respectively, and 0.11 (0.06-0.21; P < 0.0001) for the active control. Sleep-risk ratios were similar for Lisdexamfetamine dimesylate 50 or 70 mg and for the active control, but Lisdexamfetamine 20 mg was associated with a greater risk of falling asleep compared with the active control (4.13 [1.97-8.67]; P = 0.0002). Generalized estimating equation analysis detected wake-promoting effects of active treatments and eliminating data imputation, suggesting model utility in future studies.
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maintenance of efficacy of Lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder randomized withdrawal design
The Journal of Clinical Psychiatry, 2012Co-Authors: Matthew Brams, Richard H Weisler, Robert L Findling, Maria Gasior, Mohamed Hamdani, Celeste M Ferreiracornwell, Liza SquiresAbstract:OBJECTIVE: To evaluate Lisdexamfetamine dimesylate maintenance of efficacy in adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Adults (aged 18-55 years) who had ADHD meeting DSM-IV-TR criteria, baseline ADHD Rating Scale-IV (ADHD-RS-IV) with adult prompts total scores of < 22, and Clinical Global Impressions-Severity of Illness (CGI-S) ratings of 1, 2, or 3 were enrolled. After previously receiving commercially available Lisdexamfetamine dimesylate (30, 50, or 70 mg/d) for ≥ 6 months with acceptable tolerability and maintaining response during a 3-week open-label phase at a stable Lisdexamfetamine dimesylate dose, the participants entered a 6-week double-blind randomized withdrawal phase on treatment with Lisdexamfetamine dimesylate (same dose) or placebo. Data were collected from April 2009 to July 2010. The primary outcome was the proportion of participants having symptom relapse (≥ 50% increase in ADHD-RS-IV score and ≥ 2 rating-point increase in CGI-S score). RESULTS: A total of 116 participants were randomized (Lisdexamfetamine dimesylate n = 56; placebo n = 60). At the randomized withdrawal phase baseline, mean (SD) ADHD-RS-IV scores for Lisdexamfetamine dimesylate and placebo were 10.6 (4.96) and 10.6 (4.82), respectively. At endpoint, 8.9% (5/56) of adults taking Lisdexamfetamine dimesylate and 75.0% (45/60) taking placebo (P < .0001) showed symptom relapse; most showed relapse after 1 and 2 weeks of the randomized withdrawal phase (4 and 0 adults taking Lisdexamfetamine dimesylate, 26 and 10 taking placebo, respectively). During the randomized withdrawal phase, treatment-emergent adverse events were reported in 48.2% and 30.0% of participants in the Lisdexamfetamine dimesylate and placebo groups, respectively. Treatment-emergent adverse events with incidence ≥ 5% in the Lisdexamfetamine dimesylate and placebo groups were headache (14.3% and 5.0%), insomnia (5.4% and 5.0%), and upper respiratory tract infection (8.9% and 0%). CONCLUSIONS: In adults with ADHD on medium- to long-term treatment, Lisdexamfetamine dimesylate demonstrated maintenance of efficacy vs placebo upon randomized withdrawal. A majority of patients given placebo showed symptom relapse by 2 weeks. The safety profile of Lisdexamfetamine dimesylate was generally consistent with previous Lisdexamfetamine dimesylate studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00877487.
Celeste M Ferreiracornwell - One of the best experts on this subject based on the ideXlab platform.
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efficacy of Lisdexamfetamine in adults with moderate to severe binge eating disorder a randomized clinical trial
JAMA Psychiatry, 2017Co-Authors: James I Hudson, Celeste M Ferreiracornwell, Susan L Mcelroy, Jana Radewonuk, Maria GasiorAbstract:Importance The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective To assess Lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults metDSM-IV-Rbinge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [Lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), Lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued Lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Interventions Lisdexamfetamine administration. Main Outcomes and Measures The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Results Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized Lisdexamfetamine responders (placebo, n = 138; Lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for Lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37;P Conclusions and Relevance Risk of binge-eating relapse over 6 months was lower in participants continuing Lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with Lisdexamfetamine than placebo. Trial Registration clinicaltrials.gov Identifier:NCT02009163
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a phase 3 multicenter open label 12 month extension safety and tolerability trial of Lisdexamfetamine dimesylate in adults with binge eating disorder
Journal of Clinical Psychopharmacology, 2017Co-Authors: Maria Gasior, Celeste M Ferreiracornwell, James I Hudson, Jana Radewonuk, Javier Quintero, Susan L McelroyAbstract:AbstractBackgroundA 12-month, open-label extension study assessed the long-term safety and tolerability of Lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED).MethodsAdults (aged 18–55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label
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efficacy and safety of Lisdexamfetamine for treatment of adults with moderate to severe binge eating disorder a randomized clinical trial
JAMA Psychiatry, 2015Co-Authors: Susan L Mcelroy, Celeste M Ferreiracornwell, James I Hudson, James E Mitchell, Denise E Wilfley, Jiannong Wang, Timothy Whitaker, J JonasAbstract:Importance Binge-eating disorder (BED), a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome, lacks approved pharmacotherapies. Objective To examine the efficacy and safety of Lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to severe BED. Design, Setting, and Participants We performed a randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial at 30 sites from May 10, 2011, through January 30, 2012. Safety and intention-to-treat analyses included 259 and 255 adults with BED, respectively. Interventions Lisdexamfetamine dimesylate at dosages of 30, 50, or 70 mg/d or placebo were provided to study participants (1:1:1:1). Dosages were titrated across 3 weeks and maintained for 8 weeks. We followed up participants for a mean (SD) of 7 (2) days after the last dose. Main Outcomes and Measures We assessed the change in binge-eating (BE) behaviors measured as days per week (baseline to week 11) with a mixed-effects model using transformed log (BE days per week) + 1. Secondary measures included BE cessation for 4 weeks. Safety assessments included treatment-emergent adverse events, vital signs, and change in weight. Results At week 11, log-transformed BE days per week decreased with the 50-mg/d (least squares [LS] mean [SE] change, −1.49 [0.066];P = .008) and 70-mg/d (LS mean [SE] change, −1.57 [0.067];P Conclusions and Relevance The 50- and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days, BE cessation, and global improvement. The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder. Further investigation of Lisdexamfetamine in BED is ongoing. Trial Registration clinicaltrials.gov Identifier:NCT01291173
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maintenance of efficacy of Lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder randomized withdrawal design
The Journal of Clinical Psychiatry, 2012Co-Authors: Matthew Brams, Richard H Weisler, Robert L Findling, Maria Gasior, Mohamed Hamdani, Celeste M Ferreiracornwell, Liza SquiresAbstract:OBJECTIVE: To evaluate Lisdexamfetamine dimesylate maintenance of efficacy in adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Adults (aged 18-55 years) who had ADHD meeting DSM-IV-TR criteria, baseline ADHD Rating Scale-IV (ADHD-RS-IV) with adult prompts total scores of < 22, and Clinical Global Impressions-Severity of Illness (CGI-S) ratings of 1, 2, or 3 were enrolled. After previously receiving commercially available Lisdexamfetamine dimesylate (30, 50, or 70 mg/d) for ≥ 6 months with acceptable tolerability and maintaining response during a 3-week open-label phase at a stable Lisdexamfetamine dimesylate dose, the participants entered a 6-week double-blind randomized withdrawal phase on treatment with Lisdexamfetamine dimesylate (same dose) or placebo. Data were collected from April 2009 to July 2010. The primary outcome was the proportion of participants having symptom relapse (≥ 50% increase in ADHD-RS-IV score and ≥ 2 rating-point increase in CGI-S score). RESULTS: A total of 116 participants were randomized (Lisdexamfetamine dimesylate n = 56; placebo n = 60). At the randomized withdrawal phase baseline, mean (SD) ADHD-RS-IV scores for Lisdexamfetamine dimesylate and placebo were 10.6 (4.96) and 10.6 (4.82), respectively. At endpoint, 8.9% (5/56) of adults taking Lisdexamfetamine dimesylate and 75.0% (45/60) taking placebo (P < .0001) showed symptom relapse; most showed relapse after 1 and 2 weeks of the randomized withdrawal phase (4 and 0 adults taking Lisdexamfetamine dimesylate, 26 and 10 taking placebo, respectively). During the randomized withdrawal phase, treatment-emergent adverse events were reported in 48.2% and 30.0% of participants in the Lisdexamfetamine dimesylate and placebo groups, respectively. Treatment-emergent adverse events with incidence ≥ 5% in the Lisdexamfetamine dimesylate and placebo groups were headache (14.3% and 5.0%), insomnia (5.4% and 5.0%), and upper respiratory tract infection (8.9% and 0%). CONCLUSIONS: In adults with ADHD on medium- to long-term treatment, Lisdexamfetamine dimesylate demonstrated maintenance of efficacy vs placebo upon randomized withdrawal. A majority of patients given placebo showed symptom relapse by 2 weeks. The safety profile of Lisdexamfetamine dimesylate was generally consistent with previous Lisdexamfetamine dimesylate studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00877487.