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Article ; Online: Chronic Circadian Disruption and Sleep Restriction Influence Subjective Hunger, Appetite, and Food Preference.

McHill, Andrew W / Hull, Joseph T / Klerman, Elizabeth B

2022 Volume 14, Issue 9

Abstract: Chronic circadian disruption (CCD), such as occurs during rotating shiftwork, and insufficient sleep are each independently associated with poor health outcomes, including obesity and glucose intolerance. A potential mechanism for poor health is ... ...

Abstract	Chronic circadian disruption (CCD), such as occurs during rotating shiftwork, and insufficient sleep are each independently associated with poor health outcomes, including obesity and glucose intolerance. A potential mechanism for poor health is increased energy intake (i.e., eating), particularly during the circadian night, when the physiological response to energy intake is altered. However, the contributions of CCD and insufficient sleep to subjective hunger, appetite, food preference, and appetitive hormones are not clear. To disentangle the influences of these factors, we studied seventeen healthy young adults in a 32-day in-laboratory study designed to distribute sleep, wakefulness, and energy intake equally across all phases of the circadian cycle, thereby imposing CCD. Participants were randomized to the Control (1:2 sleep:wake ratio,
MeSH term(s)	Appetite/physiology ; Food Preferences ; Ghrelin ; Humans ; Hunger/physiology ; Sleep/physiology ; Sleep Deprivation ; Young Adult
Chemical Substances	Ghrelin
Language	English
Publishing date	2022-04-26
Publishing country	Switzerland
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2518386-2
ISSN	2072-6643 ; 2072-6643
ISSN (online)	2072-6643
ISSN	2072-6643
DOI	10.3390/nu14091800
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Article ; Online: Response of peer relations and social activities to treatment with viloxazine extended-release capsules (Qelbree

Faraone, Stephen V / Gomeni, Roberto / Hull, Joseph T / Busse, Gregory D / Lujan, Brendan / Rubin, Jonathan / Nasser, Azmi

Brain and behavior

2023 Volume 13, Issue 4, Page(s) e2910

Abstract: Introduction: Attention-deficit/hyperactivity disorder (ADHD) is associated with impairments related to peer relations (PR) and social activities (SA). The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release ...

Abstract	Introduction: Attention-deficit/hyperactivity disorder (ADHD) is associated with impairments related to peer relations (PR) and social activities (SA). The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree Methods: Data were used from four Phase III placebo-controlled trials of 100 to 600 mg/day of viloxazine ER (N = 1354; 6-17 years of age). PR and SA were measured with the Peer Relations content scale of the Conners 3rd Edition Parent Short Form's Peer Relation content scale (C3PS-PR) and the Social Activities domain of the Weiss Functional Impairment Rating Scale-Parent Report's (WFIRS-P-SA) at baseline and end of study. ADHD symptoms were assessed weekly with the ADHD Rating Scale, 5th Edition. The analyses relied on the general linear mixed model with the subject as a random effect. Results: Improvement in C3PS-PR (p = .0035) and WFIRS-P-SA (p = .0029) scores were significantly greater in subjects treated with viloxazine ER compared with placebo. When using measures of clinically meaningful response, the C3PS-PR responder rate was significantly higher for viloxazine ER (19.2%) compared with placebo (14.1%) and the difference was statistically significant (p = .0311); the Number Needed to Treat (NNT) was 19.6. The WFIRS-P-SA responder rate was significantly higher for viloxazine ER (43.2%) compared with placebo (28.5%) and the difference was statistically significant (p < .0001); the NNT was 6.8. The standardized mean difference effect size for both PR and SA was 0.09. Conclusions: Viloxazine ER significantly reduces the impairment of PR and SA in children and adolescents with ADHD. Although its effects on PR and SA are modest, many ADHD patients can be expected to achieve clinically meaningful improvements in PR and SA with viloxazine ER treatment for longer than 6 weeks.
MeSH term(s)	Humans ; Child ; Adolescent ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Viloxazine/therapeutic use ; Delayed-Action Preparations/therapeutic use ; Treatment Outcome ; Double-Blind Method ; Randomized Controlled Trials as Topic
Chemical Substances	Viloxazine (5I5Y2789ZF) ; Delayed-Action Preparations
Language	English
Publishing date	2023-02-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2623587-0
ISSN	2162-3279 ; 2162-3279
ISSN (online)	2162-3279
ISSN	2162-3279
DOI	10.1002/brb3.2910
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Article ; Online: Suppression of Melatonin Secretion in Totally Visually Blind People by Ocular Exposure to White Light: Clinical Characteristics.

Hull, Joseph T / Czeisler, Charles A / Lockley, Steven W

Ophthalmology

2018 Volume 125, Issue 8, Page(s) 1160–1171

Abstract: Purpose: Although most totally visually blind individuals exhibit nonentrained circadian rhythms due to an inability of light to entrain the circadian pacemaker, a small proportion retain photic circadian entrainment, melatonin suppression, and other ... ...

Abstract	Purpose: Although most totally visually blind individuals exhibit nonentrained circadian rhythms due to an inability of light to entrain the circadian pacemaker, a small proportion retain photic circadian entrainment, melatonin suppression, and other nonimage-forming responses to light. It is thought that these responses to light persist because of the survival of melanospin-containing intrinsically photosensitive retinal ganglion cells (ipRGCs), which project primarily to the circadian pacemaker and are functionally distinct from the rod and cone photoreceptors that mediate vision. We aimed to assess the integrity of nonimage-forming photoreception in totally visually blind patients with a range of ocular disorders. Design: Within-subject, dark-controlled design. Participants: A total of 18 totally visually blind individuals (7 females; mean age ± standard deviation = 49.8±11.0 years) with various causes of blindness, including 3 bilaterally enucleated controls. Methods: Melatonin concentrations were compared during exposure to a 6.5-hour bright white light (∼7000 lux) with melatonin concentrations measured 24 hours earlier at the corresponding clock times under dim-light (4 lux) conditions. Main outcome measures: Area under the curve (AUC) for melatonin concentration. Results: Melatonin concentrations were significantly suppressed (defined as ≥33% suppression) during the bright-light condition compared with the dim-light condition in 5 of 15 participants with eyes (retinitis pigmentosa, n = 2; retinopathy of prematurity [ROP], n = 2; bilateral retinal detachments, n = 1). Melatonin concentrations remained unchanged in response to light in the remaining 10 participants with eyes (ROP, n = 3; optic neuritis/neuropathy, n = 2; retinopathy unknown, n = 2; congenital glaucoma, n = 1; congenital rubella syndrome, n = 1; measles retinopathy, n = 1) and in all 3 bilaterally enucleated participants. Conclusions: These data confirm that light-induced suppression of melatonin remains functionally intact in a minority of totally visually blind individuals with eyes. None of the bilaterally enucleated individuals or those with phthisis bulbi was responsive to light; of the remainder, half were responsive to light. Although inner retinal damage is associated with a high likelihood that nonimage-forming photoreception is absent, the impact of outer retinal damage is more ambiguous, and therefore the assessment of the presence, attenuation, or absence of nonimage-forming light responses in totally blind patients requires careful individual confirmation and cannot simply be assumed from the type of blindness.
MeSH term(s)	Adult ; Aged ; Biomarkers/metabolism ; Blindness/metabolism ; Blindness/physiopathology ; Circadian Rhythm/physiology ; Female ; Humans ; Male ; Melatonin/metabolism ; Middle Aged ; Photic Stimulation ; Retinal Ganglion Cells/metabolism ; Visual Perception/physiology ; Visually Impaired Persons
Chemical Substances	Biomarkers ; Melatonin (JL5DK93RCL)
Language	English
Publishing date	2018-04-04
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	392083-5
ISSN	1549-4713 ; 0161-6420
ISSN (online)	1549-4713
ISSN	0161-6420
DOI	10.1016/j.ophtha.2018.01.036
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Article: Sleep Restriction and Recurrent Circadian Disruption Differentially Affects Blood Pressure, Sodium Retention, and Aldosterone Secretion.

McMullan, Ciaran J / McHill, Andrew W / Hull, Joseph T / Wang, Wei / Forman, John P / Klerman, Elizabeth B

Frontiers in physiology

2022 Volume 13, Page(s) 914497

Abstract: Prolonged exposure to chronic sleep restriction (CSR) and shiftwork are both associated with incident hypertension and cardiovascular disease. We hypothesized that the combination of CSR and shiftwork's rotating sleep schedule (causing recurrent ... ...

Abstract	Prolonged exposure to chronic sleep restriction (CSR) and shiftwork are both associated with incident hypertension and cardiovascular disease. We hypothesized that the combination of CSR and shiftwork's rotating sleep schedule (causing recurrent circadian disruption, RCD) would increase blood pressure, renal sodium retention, potassium excretion, and aldosterone excretion. Seventeen healthy participants were studied during a 32-day inpatient protocol that included 20-h "days" with associated scheduled sleep/wake and eating behaviors. Participants were randomly assigned to restricted (1:3.3 sleep:wake, CSR group) or standard (1:2 sleep:wake, Control group) ratios of sleep:wake duration. Systolic blood pressure during circadian misalignment was ∼6% higher in CSR conditions. Renal sodium and potassium excretion showed robust circadian patterns; potassium excretion also displayed some influence of the scheduled behaviors (sleep/wake, fasting during sleep so made parallel fasting/feeding). In contrast, the timing of renal aldosterone excretion was affected predominately by scheduled behaviors. Per 20-h "day," total sodium excretion increased, and total potassium excretion decreased during RCD without a change in total aldosterone excretion. Lastly, a reduced total renal sodium excretion was found despite constant oral sodium consumption and total aldosterone excretion, suggesting a positive total body sodium balance independent of aldosterone excretion. These findings may provide mechanistic insight into the observed adverse cardiovascular and renal effects of shiftwork.
Language	English
Publishing date	2022-07-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2564217-0
ISSN	1664-042X
ISSN	1664-042X
DOI	10.3389/fphys.2022.914497
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Article ; Online: Authors' Reply to Singh and Balasundaram: Comment on "A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder".

Nasser, Azmi / Hull, Joseph T / Liranso, Tesfaye / Fry, Nicholas / Cutler, Andrew J / Rubin, Jonathan / Childress, Ann

CNS drugs

2022 Volume 36, Issue 12, Page(s) 1333–1335

MeSH term(s)	Adult ; Humans ; Viloxazine/therapeutic use ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Delayed-Action Preparations/therapeutic use ; Methylphenidate/therapeutic use ; Central Nervous System Stimulants/therapeutic use ; Double-Blind Method ; Capsules/therapeutic use
Chemical Substances	Viloxazine (5I5Y2789ZF) ; Delayed-Action Preparations ; Methylphenidate (207ZZ9QZ49) ; Central Nervous System Stimulants ; Capsules
Language	English
Publishing date	2022-11-04
Publishing country	New Zealand
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Letter ; Comment
ZDB-ID	1203800-3
ISSN	1179-1934 ; 1172-7047
ISSN (online)	1179-1934
ISSN	1172-7047
DOI	10.1007/s40263-022-00967-5
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Article ; Online: The role of placebo response in the efficacy outcome assessment in viloxazine extended-release pivotal trials in paediatric subjects with attention-deficit/hyperactivity disorder.

Nasser, Azmi / Gomeni, Roberto / Wang, Zhao / Hull, Joseph T / Busse, Gregory D / Melyan, Zare / Fava, Maurizio / O'Neal, Welton / Rubin, Jonathan

British journal of clinical pharmacology

2022 Volume 88, Issue 11, Page(s) 4828–4838

Abstract: Aims: Four Phase 3 studies evaluated efficacy and safety of viloxazine extended-release in the treatment of attention-deficit/hyperactivity disorder (ADHD). The primary efficacy objective-change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) Total ... ...

Abstract	Aims: Four Phase 3 studies evaluated efficacy and safety of viloxazine extended-release in the treatment of attention-deficit/hyperactivity disorder (ADHD). The primary efficacy objective-change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) Total score at end of study (EOS)-was not met in one of the studies (812P304). A band-pass analysis was performed to evaluate the impact of placebo response on the results. Methods: The distribution of placebo response at EOS of each trial was evaluated. The 2.5 Results: The 2.5 Conclusion: This analysis indicated that a higher placebo response in Study 812P304 confounded the assessment of treatment effect. Application of the band-pass methodology confirmed the positive results of the 3 prior studies and the signal detection confounder in the fourth study.
MeSH term(s)	Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants ; Child ; Clinical Trials, Phase III as Topic ; Delayed-Action Preparations/therapeutic use ; Dose-Response Relationship, Drug ; Humans ; Outcome Assessment, Health Care ; Placebo Effect ; Treatment Outcome ; Viloxazine/therapeutic use
Chemical Substances	Central Nervous System Stimulants ; Delayed-Action Preparations ; Viloxazine (5I5Y2789ZF)
Language	English
Publishing date	2022-06-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15412
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Article: The Effect of Viloxazine Extended-Release Capsules on Functional Impairments Associated with Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents in Four Phase 3 Placebo-Controlled Trials.

Nasser, Azmi / Hull, Joseph T / Liranso, Tesfaye / Busse, Gregory D / Melyan, Zare / Childress, Ann C / A Lopez, Frank / Rubin, Jonathan

Neuropsychiatric disease and treatment

2021 Volume 17, Page(s) 1751–1762

Abstract: Purpose: The ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity and has been used in many clinical trials to evaluate the treatment effect of drugs on ADHD. The fifth edition of this scale (ADHD-RS-5) also ... ...

Abstract	Purpose: The ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity and has been used in many clinical trials to evaluate the treatment effect of drugs on ADHD. The fifth edition of this scale (ADHD-RS-5) also assesses the impact of inattention and hyperactivity/impulsivity symptoms on six domains of functional impairment (FI): family relationships, peer relationships, completing/returning homework, academic performance at school, controlling behavior at school, and self-esteem. Here, we report the effect of viloxazine extended-release capsules (viloxazine ER), a novel nonstimulant treatment for ADHD in children and adolescents (ages 6-17 years), on FI from a post hoc analysis of four randomized, double-blind, placebo-controlled Phase 3 clinical trials (N=1354). Patients and methods: ADHD-RS-5 investigator ratings of ADHD symptoms and FIs were conducted at baseline and weekly post-baseline for 6-8 weeks in the four trials. Change from baseline (CFB) in ADHD-RS-5 FI scores (Total score [sum of 12 FI items] and Inattention and Hyperactivity/Impulsivity subscale scores [sum of 6 corresponding FI items]) and the 30% and 50% Responder Rates (ADHD-RS-5 FI Total score) were compared between viloxazine ER and placebo. Results: The reduction (improvement) in ADHD-RS-5 FI scores (Total and subscale scores) and the percentage of responders (30% and 50%) at Week 6 were significantly greater in each viloxazine ER dose group vs placebo. In the 100-400 mg/day viloxazine ER groups, improvements were found as early as Week 1 (100-mg/day) or Week 2 (200-, 400-mg/day) of treatment. Analysis of individual items of ADHD-related FIs demonstrated that the effect of viloxazine ER was observed across all domains of impairment. Conclusion: Significant improvements observed in ADHD-related FIs are consistent with the reduction in inattention and hyperactivity/impulsivity symptoms demonstrated in the viloxazine ER Phase 3 pediatric trials. Therefore, viloxazine ER provides clinically meaningful improvement of ADHD symptoms and functioning in children and adolescents with ADHD, starting as early as Week 1-2 of treatment.
Language	English
Publishing date	2021-06-03
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2186503-6
ISSN	1178-2021 ; 1176-6328
ISSN (online)	1178-2021
ISSN	1176-6328
DOI	10.2147/NDT.S312011
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Article ; Online: A post hoc analysis of the effect of viloxazine extended-release capsules on learning and school problems in children and adolescents with attention-deficit/hyperactivity disorder.

Faraone, Stephen V / Gomeni, Roberto / Hull, Joseph T / Busse, Gregory D / Melyan, Zare / Rubin, Jonathan / Nasser, Azmi

European child & adolescent psychiatry

2021 Volume 32, Issue 3, Page(s) 491–499

Abstract: Improvement in attention-deficit/hyperactivity disorder (ADHD) symptoms vs. placebo was reported in a series of pediatric clinical trials of viloxazine extended-release capsules (viloxazine ER; Qelbree™). This post hoc analysis of those studies evaluated ...

Abstract	Improvement in attention-deficit/hyperactivity disorder (ADHD) symptoms vs. placebo was reported in a series of pediatric clinical trials of viloxazine extended-release capsules (viloxazine ER; Qelbree™). This post hoc analysis of those studies evaluated the effect of viloxazine ER on learning and school problems (LSPs). We used data from four Phase 3 placebo-controlled trials of 100-600 mg/day viloxazine ER (N = 1354; 6-17 years of age). LSPs were evaluated using the School domain of the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P-S) and the Learning Problems content scale of the Conners 3rd Edition-Parent Short Form (C3PS-LP) at baseline and end of study (≥ Week 6). ADHD symptoms were assessed weekly using the ADHD Rating Scale 5th Edition. The analyses were performed using the general linear mixed model with participant as a random effect. The responder analyses were performed using the Chi-square test. Viloxazine ER demonstrated significantly greater improvements in WFIRS-P-S (p < 0.0001) and C3PS-LP (p = 0.0113) scores vs. placebo. The response rate for the WFIRS-P-S was significantly greater for viloxazine ER vs. placebo (p = 0.001), and the number needed to treat (NNT) was 10.3 (effect size 0.7). Conversely, response rates for C3PS-LP did not differ between groups (p = 0.9069). In addition to ADHD symptoms improvement demonstrated in previous studies, viloxazine ER significantly reduced LSPs in pediatric subjects with ADHD. The responder analyses and NNT estimates indicate that a substantial number of children and adolescents with ADHD treated with viloxazine ER improved in clinically assessed LSPs.
MeSH term(s)	Adolescent ; Child ; Humans ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants/therapeutic use ; Delayed-Action Preparations/therapeutic use ; Dose-Response Relationship, Drug ; Double-Blind Method ; Schools ; Treatment Outcome ; Viloxazine/therapeutic use
Chemical Substances	Central Nervous System Stimulants ; Delayed-Action Preparations ; Viloxazine (5I5Y2789ZF)
Language	English
Publishing date	2021-09-28
Publishing country	Germany
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	1118299-4
ISSN	1435-165X ; 1018-8827 ; 1433-5719
ISSN (online)	1435-165X
ISSN	1018-8827 ; 1433-5719
DOI	10.1007/s00787-021-01877-5
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Article ; Online: Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials.

Faraone, Stephen V / Gomeni, Roberto / Hull, Joseph T / Busse, Gregory D / Melyan, Zare / Rubin, Jonathan / Nasser, Azmi

Paediatric drugs

2021 Volume 23, Issue 6, Page(s) 583–589

Abstract: Aim: The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD).! ...

Abstract	Aim: The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD). Methods: Data from four phase III placebo-controlled trials of 100-600 mg/day viloxazine ER (6-8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form-Executive Function (C3PS-EF) content scale T-score. Subjects were defined as EFD responders if they had C3PS-EF T-score > 70 at baseline and < 65 at end of study. ADHD symptoms were assessed with ADHD Rating Scale 5th Edition (ADHD-RS-5). Subjects were defined as ADHD symptom responders if they had a ≥ 50% reduction in CFB ADHD-RS-5 Total score at Week 6. The number needed to treat (NNT) and Cohen's d effect sizes were estimated for EFD and ADHD symptoms. Results: A total of 1154 subjects were included in the analysis. Statistically significant improvements in EFDs were observed with viloxazine ER versus placebo (p = 0.0002). There were 52.5% of EFD or ADHD symptom responders in the viloxazine ER treatment group and 35.4% in the placebo group (p < 0.0001). The NNT was 5.8. The Cohen's d effect size for EFD and ADHD symptoms was 0.31. Conclusion: Consistent with the efficacy of viloxazine ER demonstrated in pivotal trials, viloxazine ER significantly reduced EFDs in subjects with ADHD. Moreover, a substantial proportion of subjects treated with viloxazine ER had large improvements in EFDs, ADHD symptoms, or both. Clinical trial registration numbers: NCT03247530, NCT03247517, NCT03247543, NCT03247556.
MeSH term(s)	Adolescent ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants ; Child ; Delayed-Action Preparations ; Dose-Response Relationship, Drug ; Double-Blind Method ; Executive Function ; Humans ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Viloxazine/therapeutic use
Chemical Substances	Central Nervous System Stimulants ; Delayed-Action Preparations ; Viloxazine (5I5Y2789ZF)
Language	English
Publishing date	2021-09-15
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1492748-2
ISSN	1179-2019 ; 1174-5878
ISSN (online)	1179-2019
ISSN	1174-5878
DOI	10.1007/s40272-021-00470-2
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Article ; Online: Early response to SPN-812 (viloxazine extended-release) can predict efficacy outcome in pediatric subjects with ADHD: a machine learning post-hoc analysis of four randomized clinical trials.

Faraone, Stephen V / Gomeni, Roberto / Hull, Joseph T / Busse, Gregory D / Melyan, Zare / O'Neal, Welton / Rubin, Jonathan / Nasser, Azmi

Psychiatry research

2021 Volume 296, Page(s) 113664

Abstract: Machine learning (ML) was used to determine whether early response can predict efficacy outcome in pediatric subjects with ADHD treated with SPN-812. We used data from four Phase 3 placebo-controlled trials of 100- to 600-mg/day SPN-812 (N=1397; 6-17 ... ...

Abstract	Machine learning (ML) was used to determine whether early response can predict efficacy outcome in pediatric subjects with ADHD treated with SPN-812. We used data from four Phase 3 placebo-controlled trials of 100- to 600-mg/day SPN-812 (N=1397; 6-17 years of age). The treatment response was defined as having a ≥50% reduction in change from baseline (CFB) in ADHD Rating Scale-5 (ADHD-RS-5) Total score at Week 6. The variables used were: ADHD-RS-5 Total score, age, body weight, and body mass index at baseline; CFB ADHD-RS-5 Total score at Week 1, cumulative change in ADHD-RS-5 Total score at Week 2, and cumulative change in ADHD-RS-5 Total score at Week 3; Clinical Global Impressions-Improvement (CGI-I) score at Week 1, 2, and 3; and target dose. Using the best selected model, lasso regression, to generate importance scores, we found that change in ADHD-RS-5 Total score and CGI-I score were the best predictors of efficacy outcome. Change in ADHD-RS-5 Total score at Week 2 could predict treatment response at Week 6 (75% positive predictive power, 75% sensitivity, 74% specificity). Therefore, early response after two weeks of treatment with once-daily SPN-812 in pediatric patients with ADHD can predict efficacy outcome at Week 6.
MeSH term(s)	Adolescent ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Body Mass Index ; Body Weight ; Central Nervous System Stimulants/administration & dosage ; Central Nervous System Stimulants/therapeutic use ; Child ; Clinical Trials as Topic ; Delayed-Action Preparations/administration & dosage ; Delayed-Action Preparations/therapeutic use ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Machine Learning ; Male ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Viloxazine/administration & dosage ; Viloxazine/therapeutic use
Chemical Substances	Central Nervous System Stimulants ; Delayed-Action Preparations ; Viloxazine (5I5Y2789ZF)
Language	English
Publishing date	2021-01-05
Publishing country	Ireland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	445361-x
ISSN	1872-7123 ; 1872-7506 ; 0925-4927 ; 0165-1781
ISSN (online)	1872-7123 ; 1872-7506
ISSN	0925-4927 ; 0165-1781
DOI	10.1016/j.psychres.2020.113664
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In stock of ZB MED Cologne/Königswinter

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Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito