0000000000053524
AUTHOR
Michael Huss
showing 31 related works from this author
Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study.
2015
Background Extended-release guanfacine hydrochloride (GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase …
Distinguishing the efficacy and sedative effects of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity diso…
2019
The present study investigated whether symptom reduction in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with guanfacine extended release (GXR) can be explained by sedative effects of the medication. Data from four double-blind, randomized, placebo-controlled, phase 3 trials of GXR monotherapy (1-7 mg/day; morning administration) in children (aged 6-12 years) and adolescents (aged 13-17 years) with ADHD were analyzed post hoc. Two studies used forced-dose titration and two used flexible-dose titration. Efficacy was determined using ADHD Rating Scale IV (ADHD-RS-IV) scores. Sedative treatment-emergent adverse events (TEAEs) included somnolence, sedati…
Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: Efficacy following prior methylphenidate trea…
2016
Guanfacine extended release (GXR) and atomoxetine (ATX) are nonstimulant treatments for attention-deficit/hyperactivity disorder (ADHD). As nonstimulant treatments are often used after stimulants in ADHD, GXR was assessed relative to prior stimulant treatment in a randomized controlled trial (RCT), in which ATX was included as a reference arm, and in the open-label phase of a randomized-withdrawal study (RWS). Participants were 6–17 years old with ADHD Rating Scale version IV (ADHD-RS-IV) scores ≥32 and Clinical Global Impressions – Severity scores ≥4. RCT participants received dose-optimized GXR (1–7 mg/day), ATX (10–100 mg/day), or placebo for 10–13 weeks. RWS participants received dose-o…
Systematic review of transdermal treatment options in attention-deficit/hyperactivity disorder: implications for use in adult patients.
2021
Abstract Background Adults with attention-deficit/hyperactivity disorder (ADHD) often face delays in diagnosis and remain untreated, despite significant negative impacts. To evaluate the safety and efficacy of transdermal treatment options in children, adolescents, and adults, a systematic literature review was conducted, with a focus on the implications of transdermal therapies for ADHD in adults. Methods A MEDLINE/Embase/BIOSIS/SCOPUS database search was conducted December 4, 2019, for English-language articles of interventional clinical trials using transdermal formulations for the treatment of ADHD without publication date limit. Assessed outcomes included efficacy, safety, adherence, a…
Efficacy of Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant D…
2020
OBJECTIVE To assess the efficacy of the non-stimulant guanfacine extended release (GXR) on attention-deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents, with and without comorbid oppositional defiant disorder (ODD). METHODS Data were derived from 4 phase 3, randomized, placebo-controlled trials of dose-optimized GXR monotherapy, in which at least 10% of participants had a diagnosis of comorbid ODD. SPD503-312 and SPD503-316 were 10- to 13-week studies of GXR (1-7 mg/d). SPD503-314 and SPD503-307 were 8-week studies of GXR (1-4 mg/d). Efficacy was assessed using the ADHD Rating Scale IV (ADHD-RS-IV) total scores. RESULTS In total, 1,084 participants were included (SPD…
Under diagnosis of adult ADHD: cultural influences and societal burden.
2012
Objective: To explore the literature focusing on cultural influences in the diagnosis of adult ADHD and respective societal burden. Method: A review of the literature over the past 10 years was performed using OVID. Results: Although numerous articles focused on diagnosis and burden of adult ADHD, few focused on cultural factors influencing diagnosis. Like other mental health disorders, cultural and social perspectives contribute to our understanding of adult ADHD and may play a significant role in the diagnosis and varying acceptance of the condition. Moreover, adults with ADHD may underestimate the impact of ADHD symptoms, and in many cases have learned to compensate for ADHD related imp…
Attention-deficit/hyperactivity disorder in adults: update on clinical presentation and care
2014
Attention-deficit/hyperactivity disorder (ADHD) is characterized by traitlike symptoms, with stable features frequently emerging in early childhood and persisting throughout adolescence and adulthood. The hallmarks are pervasive, developmentally inappropriate levels of inattention, hyperactivity and impulsivity leading to impairments in family life, social life, academic performance, and occupational functioning. Emotional lability is a commonly associated feature that is a further source of impairment. Diagnosis rests on a comprehensive assessment of developmental psychiatric history and current status, following DSM-5 guidelines on ADHD classification and diagnostic thresholds for adults.…
Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients – Results of the COMPAS Study
2020
Abstract Introduction The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety. Methods MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an “as received” basis during week 0–52. Electrocardiogram data were recorded at baseline and week 24. Results Comparing 205 patients who received ≥1 dose of MPH with 209 patients wh…
EPA-0666 – Long-term maintenance of efficacy of extended-release guanfacine hydrochloride (GXR) in children and adolescents with attention-deficit/hy…
2014
Introduction GXR, a selective α2A-adrenergic agonist, is a non-stimulant ADHD treatment approved in the USA for children and adolescents, and in Canada for children. Objectives To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial. Aims To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145). Methods Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimiz…
Long-term improvement of quality of life in adult ADHD – results of the randomized multimodal COMPAS trial
2021
Attention Deficit Hyperactivity Disorder (ADHD) negatively impacts Quality of Life (QoL) in adults. Earlier studies on pharmacological treatment have shown short-term beneficial effects on QoL. No data are available on long-term effects on multimodal psychosocial and/or pharmacological interventions. The Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS), a prospective, multicenter randomized clinical trial, compared cognitive behavioral group psychotherapy (GPT) with individual clinical management (CM) and methylphenidate (MPH) with placebo (Plac) (2 × 2 factorial design over a period of 52 weeks). Change of QoL was measured after three months of intensive treatme…
Consortium for the lifespan examination of ADHD registry (Clear): An update on methodology and recruitment
2011
IntroductionADHD is often unrecognised and untreated, particularly in Europe. There is a need for improved understanding of ADHD in adults and its impact on patients across the lifespan. Registries allow for multiple real-world comparisons based on assessment of patients that are typically excluded from clinical studies. Data describing the cost, burden and consequences of ADHD are essential to inform clinicians, regulatory agencies, payers and patients about the condition.ObjectivesTo address the gaps in our current understanding of the care and cost of treating adult patients with ADHD by documenting real-life experiences.MethodsA prospective, longitudinal, observational study of adults &…
Separating efficacy and sedative effects of guanfacine extended release in children and adolescents with ADHD from four randomized, controlled, phase…
2016
IntroductionGuanfacine extended release (GXR) is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD).ObjectiveTo separate efficacy and sedative treatment-emergent adverse events (TEAEs) associated with GXR in four randomized, controlled trials in children (6–12 years) and adolescents (13–17 years) with ADHD.MethodsSPD503-301 (n = 345) and SPD503-304 (n = 324) were 8 and 9 week studies of fixed-dose GXR (≤ 4 mg/day). SPD503-312 (n = 314; adolescents only) and SPD503-316 (n = 338) were 10–13 week studies of dose-optimized GXR (1–7 mg/day).ResultsIn fixed-dose studies, pooled incidences of sedative TEAEs with GXR were highest at week 1 (GXR, 13.9–18.7%; placebo, 8.7%)…
Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: A randomi…
2014
AbstractGuanfacine extended-release (GXR), a selective α2A-adrenergic agonist, is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD). This study assessed the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo. Patients (6–17 years) were randomized at baseline to dose-optimized GXR (0.05–0.12mg/kg/day – 6–12 years: 1–4mg/day; 13–17 years: 1–7mg/day), ATX (10–100mg/day) or placebo for 4 or 7 weeks. The primary efficacy measure was change from baseline in ADHD Rating Scale version IV (ADHD-RS-IV). Key secondary me…
Momentary emotion identification in female adolescents with and without anorexia nervosa.
2017
Individuals with anorexia nervosa (AN) often report difficulties in identifying emotions, which have been mostly studied as an alexithymia trait. In a controlled two-day ecological momentary assessment, we studied the influence of time of day and aversive tension on self-reported momentary emotion identification. Analysis on an aggregated level revealed a significant lower mean emotion identification in the AN group. In a mixed model analysis, the AN group showed lower emotion identification than the control group (HC). Both a general and a group effect of time of day were found, indicating that emotion identification improved during the day in HC, whereas a negligible decrease of the emoti…
Childhood methylphenidate treatment of ADHD and response to affective stimuli
2009
Neural correlates of emotional dysregulation in attention-deficit/hyperactivity disorder (ADHD) and persisting influence of Methylphenidate (MPH) still remain insufficiently understood. Decreased activation in the subgenual cingulate and the ventral striatum were found during the perception of positive and negative affective pictures in drug-naïve males with ADHD during childhood (n=10). Males with ADHD during childhood treated with MPH (n=10) did not show any significant differences compared to healthy controls (n=10). Further prospective studies need to clarify direct and indirect mechanisms of MPH treatment that may contribute to emotional processing, which is dysfunctional in males with…
EEG Data Quality: Determinants and Impact in a Multicenter Study of Children, Adolescents, and Adults with Attention-Deficit/Hyperactivity Disorder (…
2021
Electroencephalography (EEG) represents a widely established method for assessing altered and typically developing brain function. However, systematic studies on EEG data quality, its correlates, and consequences are scarce. To address this research gap, the current study focused on the percentage of artifact-free segments after standard EEG pre-processing as a data quality index. We analyzed participant-related and methodological influences, and validity by replicating landmark EEG effects. Further, effects of data quality on spectral power analyses beyond participant-related characteristics were explored. EEG data from a multicenter ADHD-cohort (age range 6 to 45 years), and a non-ADHD sc…
Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD
2017
Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Ach…
Supplementation of polyunsaturated fatty acids, magnesium and zinc in children seeking medical advice for attention-deficit/hyperactivity problems - …
2010
Abstract Background Polyunsaturated fatty acids are essential nutrients for humans. They are structural and functional components of cell membranes and pre-stages of the hormonally and immunologically active eicosanoids. Recent discoveries have shown that the long-chained omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) also play an important role in the central nervous system. They are essential for normal brain functioning including attention and other neuropsychological skills. Materials and methods In our large observational study we monitored 810 children from 5 to 12 years of age referred for medical help and recommended for consuming polyunsaturated fatt…
German validation of the conners adult ADHD rating scale-self-report: confirmation of factor structure in a large sample of participants with ADHD.
2013
Objective: The Conners Adult ADHD Rating Scales (CAARS) assess symptoms specific to adults that are frequently used and have been translated into German. The current study tests the factor structure of the CAARS in a large sample of German adults with ADHD and compares the means of the CAARS subscales with those of healthy German participants. Method: CAARS were completed by 466 participants with ADHD and 851 healthy control participants. Confirmatory factor analysis was used to establish model fit with the American original. Comparisons between participants with ADHD and healthy controls and influences of gender, age, and degree of education were analyzed. Results: Confirmatory factor anal…
Disturbed brain activation during a working memory task in drug-naive adult patients with ADHD.
2010
Neuroimaging studies in attention-deficit/hyperactivity disorder (ADHD) have shown abnormalities in several brain areas including the frontostriatal circuitry and were mostly conducted in children and adolescents. We investigated 30 never-medicated adult ADHD patients (16 males) and 30 matched healthy control individuals. Functional magnetic resonance imaging was acquired during a working memory paradigm (n-back). Group activation maps and group differences of activation were calculated using voxel-based analyses. The generic activation pattern was more extended in the control group. In ADHD patients, significantly decreased activation was found in the right inferior parietal cortex. Distur…
Long-term Effects of Multimodal Treatment on Adult Attention-Deficit/Hyperactivity Disorder Symptoms: Follow-up Analysis of the COMPAS Trial.
2019
Key Points Question What are the long-term results of multimodal treatment for adult attention-deficit/hyperactivity disorder (ADHD) when comparing cognitive behavioral group psychotherapy (GPT) with individual clinical management (CM) in combination with either methylphenidate or placebo? Findings In this follow-up assessment of the Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS), a multicenter randomized clinical trial, 256 adults participated in follow-up 1.5 years after the intervention ended. The severity of ADHD symptoms improved in all 4 prior treatment groups, with no significant difference found between GPT and CM, but methylphenidate was associated wit…
Prevalence, determinants and spectrum of attention-deficit hyperactivity disorder (ADHD) medication of children and adolescents in Germany: results o…
2012
Objective To investigate the prevalence, determinants and spectrum of attention-deficit hyperactivity disorder (ADHD) medication and its associations with socioeconomic status (SES), health-related behaviour and living conditions. Design Observational cross-sectional study. Setting Germany. Participants Representative population-based sample of non-institutionalised youth aged between 0 and 17 years (n=17 450) and examined between 2003 and 2006. Main outcome measure Prevalence and spectrum of ADHD medication (Anatomical Therapeutic Chemical (ATC) code N04BA) measured by standardised computer-assisted personal interview (CAPI) on drug use. Results The overall prevalence of ADHD medication (s…
Effectiveness of Psychotherapy in Adult ADHD: What Do Patients Think? Results of the COMPAS Study
2017
Objective: In the multicenter study Comparison of Methylphenidate and Psychotherapy in Adult ADHD (COMPAS), the efficacy of treatments has been primarily evaluated by observer-rated symptom change. Here, we additionally analyzed the patients’ subjective evaluation of therapy effects. Method: COMPAS compared ADHD-specific group therapy with unspecific clinical management with/without concomitant pharmacotherapy in a four-armed design. Evaluation through the patients’ retrospective perspective was performed after 1 year (post-treatment) and after another 1.5 years (follow-up). Results: In respect to patients’ subjective ratings, ADHD-specific group psychotherapy outperformed unspecific manage…
German validation of the Conners Adult ADHD Rating Scales (CAARS) II: reliability, validity, diagnostic sensitivity and specificity.
2010
AbstractBackgroundThe German version of the Conners Adult ADHD Rating Scales (CAARS) has proven to show very high model fit in confirmative factor analyses with the established factors inattention/memory problems, hyperactivity/restlessness, impulsivity/emotional lability, and problems with self-concept in both large healthy control and ADHD patient samples. This study now presents data on the psychometric properties of the German CAARS-self-report (CAARS-S) and observer-report (CAARS-O) questionnaires.MethodsCAARS-S/O and questions on sociodemographic variables were filled out by 466 patients with ADHD, 847 healthy control subjects that already participated in two prior studies, and a tota…
Seasonal variation of BMI at admission in German adolescents with anorexia nervosa.
2018
Objective Recent preliminary studies indicated a seasonal association of BMI at admission to inpatient treatment for anorexia nervosa (AN), indicating lower BMI in the cold season for restrictive AN. An impaired thermoregulation was proposed as the causal factor, based on findings in animal models of AN. However, findings regarding seasonality of BMI and physical activity levels in the general population indicate lower BMI and higher physical activity in summer than in winter. Therefore, we aimed to thoroughly replicate the findings regarding seasonality of BMI at admission in patients with AN in this study. Method AN subtype, age- and gender-standardized BMI scores (BMI-SDS) at admission, …
Toward a Dimensional Assessment of Externalizing Disorders in Children : Reliability and Validity of a Semi-Structured Parent Interview
2020
Objective: This study assesses the reliability and validity of the DSM-5-based, semi-structured Clinical Parent Interview for Externalizing Disorders in Children and Adolescents (ILF-EXTERNAL). Method: Participant data were drawn from the ongoing ESCAschool intervention study. The ILF-EXTERNAL was evaluated in a clinical sample of 474 children and adolescents (aged 6−12 years, 92 females) with symptoms of attention-deficit/hyperactivity disorder (ADHD). To obtain interrater reliability, the one-way random-effects, absolute agreement models of the intraclass correlation (ICC) for single ICC(1,1) and average measurements ICC(1,3) were computed between the interviewers and two independent rate…
Effectiveness and safety of dexamphetamine sulfate (Attentin
2021
Abstract Background: Randomized controlled trials have shown that dexamphetamine sulfate (DEX) is efficacious in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents; however, data on the effectiveness and safety of DEX in routine practice are scarce. Objective: This study investigated the long-term effectiveness and safety of Attentin® (immediate-release DEX) in children and adolescents with ADHD in routine practice. Methods: ATTENTION was a multicenter, prospective, observational, non-interventional study that enrolled pediatric patients with ADHD (aged 6-17 years) with a clinically inadequate response to previous methylphenidate (MPH) treatment. Pa…
Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder
2015
Importance Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with high prevalence in adulthood. There is a recognized need to assess the efficacy of psychotherapy in adult ADHD. Objective To evaluate the efficacy of cognitive behavioral group psychotherapy (GPT) compared with individual clinical management (CM) and that of methylphenidate hydrochloride compared with placebo. Design, Setting, and Participants Prospective, multicenter, randomized clinical trial of 18- to 58-year-old outpatients with ADHD from 7 German study centers. Patients were recruited between January 2007 and August 2010, treatment was finalized in August 2011, and final follow-up assessmen…
Distinguishing Comorbidity and Successful Management of Adult ADHD
2012
Objective: Given high rates of comorbidity, lack of awareness and global acceptance, and varying guidelines for its management, adult ADHD may be an especially difficult condition to diagnose and treat. The objective of this review was to explore and characterize similarities and differences among comorbidities associated with adult ADHD. Method: A review of the literature over the past 10 years was performed using Ovid. Results: A myriad of comorbid conditions such as impulse-control/personality, anxiety, mood, substance use, learning, and sleep disorders overlap with adult ADHD. Furthermore, a number of such conditions have symptoms that can mimic those of ADHD, including hyperactivity, …
EPA-0685 – Guanfacine XR (GXR) for children and adolescents with attention-deficit/hyperactivity disorder (ADHD): phase 3, randomized, double-blind, …
2014
Introduction GXR, a selective α2A-adrenergic agonist, is a non-stimulant treatment for ADHD (approved in the USA for children and adolescents and in Canada for children). Objectives To assess the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD. Aims To evaluate the efficacy (symptom and function) and safety of GXR for the treatment of ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo (NCT01244490). Methods Patients (6–17 years) were randomly assigned at baseline to dose-optimized GXR (6–12 years, 1–4 mg/day; 13–17 years, 1–7 mg/day), ATX (10–100mg/day) or placebo for 4 or 7 week…
Treating eating disorders in the real world — MaiStep: A skill-based universal prevention for schools
2019
Eating disorders are difficult to treat and often associated with morbidity and mortality. Universal prevention approaches are increasingly focusing on enhancing skills, but few eating disorder programs are available for under-15-year-olds. This study aimed to develop and examine a school-based universal prevention program ('MaiStep') for adolescent boys and girls. A three-arm randomized controlled trial with baseline, post-intervention and 12-month follow-up was conducted with 1654 adolescents (M = 13.35, SD 0.76). 'MaiStep' was delivered by psychologists in the first intervention group (IG1) and teachers in the second intervention group (IG2), and compared to an active control group (ACG)…