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  1. Article ; Online: Viloxazine extended-release capsules as an emerging treatment for attention-deficit/hyperactivity disorder in children and adolescents.

    Maletic, Vladimir / Mattingly, Gregory W / Earnest, Jami

    Expert review of neurotherapeutics

    2024  Volume 24, Issue 5, Page(s) 443–455

    Abstract: Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention and/or hyperactivity and impulsivity. Viloxazine extended-release (ER) capsules (Qelbree®) is a US Food and Drug Administration- ... ...

    Abstract Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention and/or hyperactivity and impulsivity. Viloxazine extended-release (ER) capsules (Qelbree®) is a US Food and Drug Administration-approved nonstimulant treatment option for children, adolescents, and adults with ADHD.
    Areas covered: This review manuscript summarizes the neurobiology of ADHD and currently available treatment options before discussing viloxazine pharmacology, efficacy, safety, and tolerability data from phase II and III trials in children and adolescents (6-17 years old). Viloxazine clinical efficacy has also been further demonstrated by post hoc analyses of pediatric clinical trial results.
    Expert opinion: Current stimulant and nonstimulant treatments for ADHD may be suboptimal given low response rates and that tolerability issues are frequently experienced. Preclinical and clinical evidence has implicated both the role of catecholamine and serotonin signaling in the pathophysiology of ADHD and the pharmacologic effect of viloxazine on these critical neurotransmitter systems. With a relatively rapid onset of action, sustained symptom improvement, and clinical benefit in ADHD-associated impairments (functional and social), viloxazine ER represents a novel and emerging ADHD treatment option.
    MeSH term(s) Adult ; Adolescent ; Humans ; Child ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Viloxazine/therapeutic use ; Central Nervous System Stimulants/therapeutic use ; Delayed-Action Preparations/therapeutic use ; Treatment Outcome
    Chemical Substances Viloxazine (5I5Y2789ZF) ; Central Nervous System Stimulants ; Delayed-Action Preparations
    Language English
    Publishing date 2024-03-19
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2112534-X
    ISSN 1744-8360 ; 1473-7175
    ISSN (online) 1744-8360
    ISSN 1473-7175
    DOI 10.1080/14737175.2024.2327533
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  2. Article ; Online: Understanding the mechanism of action and clinical effects of neuroactive steroids and GABAergic compounds in major depressive disorder.

    Cutler, Andrew J / Mattingly, Gregory W / Maletic, Vladimir

    Translational psychiatry

    2023  Volume 13, Issue 1, Page(s) 228

    Abstract: The pathophysiology of major depressive disorder (MDD) is thought to result from impaired connectivity between key brain networks. Gamma-aminobutyric acid (GABA) is the key inhibitory neurotransmitter in the brain, working primarily via ... ...

    Abstract The pathophysiology of major depressive disorder (MDD) is thought to result from impaired connectivity between key brain networks. Gamma-aminobutyric acid (GABA) is the key inhibitory neurotransmitter in the brain, working primarily via GABA
    MeSH term(s) Female ; Adult ; Humans ; Depressive Disorder, Major/drug therapy ; Neurosteroids/therapeutic use ; Receptors, GABA-A ; gamma-Aminobutyric Acid ; Antidepressive Agents/pharmacology ; Antidepressive Agents/therapeutic use
    Chemical Substances Neurosteroids ; Receptors, GABA-A ; gamma-Aminobutyric Acid (56-12-2) ; Antidepressive Agents
    Language English
    Publishing date 2023-06-26
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 2609311-X
    ISSN 2158-3188 ; 2158-3188
    ISSN (online) 2158-3188
    ISSN 2158-3188
    DOI 10.1038/s41398-023-02514-2
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  3. Article ; Online: WHO Essential Medicines List and methylphenidate for ADHD in children and adolescents - Authors' reply.

    Cortese, Samuele / Coghill, David / Mattingly, Gregory W / Rohde, Luis A / Wong, Ian C K / Faraone, Stephen V

    The lancet. Psychiatry

    2024  Volume 11, Issue 2, Page(s) 93–95

    MeSH term(s) Child ; Adolescent ; Humans ; Methylphenidate/therapeutic use ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants/therapeutic use ; World Health Organization
    Chemical Substances Methylphenidate (207ZZ9QZ49) ; Central Nervous System Stimulants
    Language English
    Publishing date 2024-01-19
    Publishing country England
    Document type Letter
    ISSN 2215-0374
    ISSN (online) 2215-0374
    DOI 10.1016/S2215-0366(23)00437-6
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  4. Article ; Online: AACAP Endorses the Inclusion of Methylphenidate in the WHO Model Lists of Essential Medicines.

    Cortese, Samuele / Coghill, David / Mattingly, Gregory W / Rohde, Luis Augusto / Thom, Robyn P / Wilens, Timothy E / Wong, Ian C K / Faraone, Stephen V

    Journal of the American Academy of Child and Adolescent Psychiatry

    2024  

    Abstract: Despite decades of clinical use and a large body of evidence, the WHO continues to exclude methylphenidate for attention-deficit/hyperactivity disorder (ADHD) from its EML. ...

    Abstract Despite decades of clinical use and a large body of evidence, the WHO continues to exclude methylphenidate for attention-deficit/hyperactivity disorder (ADHD) from its EML.
    Language English
    Publishing date 2024-02-28
    Publishing country United States
    Document type Letter
    ZDB-ID 392535-3
    ISSN 1527-5418 ; 0890-8567
    ISSN (online) 1527-5418
    ISSN 0890-8567
    DOI 10.1016/j.jaac.2024.02.008
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  5. Article ; Online: ESCAP endorses the inclusion of methylphenidate in the WHO model lists of essential medicines and in the Union list of critical medicines.

    Cortese, Samuele / Coghill, David / Fegert, Joerg M / Mattingly, Gregory W / Rohde, Luis A / Wong, Ian C K / Faraone, Stephen V

    European child & adolescent psychiatry

    2024  

    Language English
    Publishing date 2024-04-25
    Publishing country Germany
    Document type Letter
    ZDB-ID 1118299-4
    ISSN 1435-165X ; 1018-8827 ; 1433-5719
    ISSN (online) 1435-165X
    ISSN 1018-8827 ; 1433-5719
    DOI 10.1007/s00787-024-02443-5
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    Zs.A 3524: Show issues Location:
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  6. Article ; Online: Long-term safety and efficacy, including anhedonia, of vortioxetine for major depressive disorder: findings from two open-label studies.

    Mattingly, Gregory W / Necking, Oscar / Schmidt, Simon Nitschky / Reines, Elin / Ren, Hongye

    Current medical research and opinion

    2023  Volume 39, Issue 4, Page(s) 613–619

    Abstract: Objective: Evaluate the long-term safety and efficacy of vortioxetine in the management of major depressive disorder (MDD) in two open-label one-year studies, including a : Methods: Both studies were 52-week, open-label, flexible-dose extension ... ...

    Abstract Objective: Evaluate the long-term safety and efficacy of vortioxetine in the management of major depressive disorder (MDD) in two open-label one-year studies, including a
    Methods: Both studies were 52-week, open-label, flexible-dose extension studies to evaluate the safety and efficacy of vortioxetine in adult patients with MDD following prior double-blind studies. Patients in the first study (NCT00761306) were flexibly treated with vortioxetine 5 or 10 mg/day (
    Results: The safety and tolerability profile of vortioxetine was similar between the two studies; treatment-emergent adverse events with the highest incidence were nausea, dizziness, headache, and nasopharyngitis. Across both studies, improvements achieved during the preceding double-blind studies period were maintained, and additional improvements were observed with open-label treatment. Patients showed a mean ± SD reduction (improvement) in Montgomery and Åsberg Depression Rating Scale (MADRS) total score from open-label baseline to Week 52 of 4.3 ± 9.2 points in the 5-10 mg study, and 10.9 ± 10.0 in the 15-20 mg study.
    Conclusions: Data from both studies confirm the safety and efficacy of flexibly dosed vortioxetine over 52 weeks of treatment and demonstrate that MADRS anhedonia factor scores continue to improve with long-term maintenance treatment.
    MeSH term(s) Adult ; Humans ; Vortioxetine/therapeutic use ; Depressive Disorder, Major/drug therapy ; Anhedonia ; Selective Serotonin Reuptake Inhibitors ; Piperazines/therapeutic use ; Sulfides/therapeutic use
    Chemical Substances Vortioxetine (3O2K1S3WQV) ; Selective Serotonin Reuptake Inhibitors ; Piperazines ; Sulfides
    Language English
    Publishing date 2023-03-08
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 80296-7
    ISSN 1473-4877 ; 0300-7995
    ISSN (online) 1473-4877
    ISSN 0300-7995
    DOI 10.1080/03007995.2023.2178082
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    Zs.A 955: Show issues Location:
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  7. Article: Assessing the educational needs of physicians in the management of patients with Tourette syndrome: results of a United States survey on practicing clinicians and caregivers.

    Stacy, Sylvie / Salinas, Gregory D / Belcher, Emily / Wilhelm, Amanda / Alexander, Jessica K / Mattingly, Gregory W

    CNS spectrums

    2022  Volume 28, Issue 3, Page(s) 343–350

    Abstract: Objective: To better understand current practices of U.S.-based physicians in the management of Tourette syndrome (TS) and identify gaps that may be addressed by future education.: Methods: Two survey instruments were developed to gather data on ... ...

    Abstract Objective: To better understand current practices of U.S.-based physicians in the management of Tourette syndrome (TS) and identify gaps that may be addressed by future education.
    Methods: Two survey instruments were developed to gather data on management of TS and perceptions from physicians and caregivers of children with TS. The clinician survey was developed in consultation with a TS physician expert and utilized clinical vignettes to assess and quantify practice patterns. The caregiver survey was adapted from the clinician survey and other published studies and gathered details on diagnosis, treatment, and perceptions regarding management.
    Results: Data included responses from 138 neurologists (including 57 pediatric neurologists), 162 psychiatrists (including 42 pediatric psychiatrists), and 67 caregivers. Most (65%) pediatric neurologists rely solely on clinical findings to make a diagnosis, whereas the majority of other specialists utilize additional testing (eg, neuroimaging, lab testing, and genetics). Most psychiatrists (96%) utilize standardized criteria to make a diagnosis, whereas 22% of neurologists do not. Many physicians (44% of psychiatrists and 20% of neurologists) use pharmacotherapy to treat a patient with "slightly bothersome" tics and no functional impairment, whereas caregivers favored behavioral therapy. Most (76%) caregivers preferred to make the final treatment decision, whereas 80% of physicians preferred equal or physician-directed decision-making.
    Conclusions: This study provides insight into practice patterns and perceptions of U.S.-based neurologists and psychiatrists in managing TS. Results highlight the potential value of physician education, including diagnostic approach, tic management and monitoring, involvement of caregivers in decision-making, and updates on TS management.
    MeSH term(s) Humans ; Child ; United States ; Tourette Syndrome/diagnosis ; Tourette Syndrome/therapy ; Caregivers ; Tic Disorders ; Tics ; Neurologists
    Language English
    Publishing date 2022-02-18
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2008418-3
    ISSN 2165-6509 ; 1092-8529
    ISSN (online) 2165-6509
    ISSN 1092-8529
    DOI 10.1017/S1092852921000766
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    Zs.A 5171: Show issues Location:
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  8. Article: Assessing the educational needs of physicians in the management of patients with Tourette syndrome: results of a United States survey on practicing clinicians and caregivers - Corrigendum.

    Stacy, Sylvie / Salinas, Gregory D / Belcher, Emily / Wilhelm, Amanda / Alexander, Jessica K / Mattingly, Gregory W

    CNS spectrums

    2022  Volume 28, Issue 3, Page(s) 387

    MeSH term(s) Humans ; United States ; Tourette Syndrome/therapy ; Caregivers ; Physicians ; Surveys and Questionnaires
    Language English
    Publishing date 2022-07-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2008418-3
    ISSN 2165-6509 ; 1092-8529
    ISSN (online) 2165-6509
    ISSN 1092-8529
    DOI 10.1017/S109285292200089X
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  9. Article ; Online: WHO Model Lists of Essential Medicines: methylphenidate for ADHD in children and adolescents.

    Cortese, Samuele / Coghill, David / Mattingly, Gregory W / Rohde, Luis A / Wong, Ian C K / Faraone, Steven V

    The lancet. Psychiatry

    2023  Volume 10, Issue 10, Page(s) 743–744

    MeSH term(s) Adolescent ; Child ; Humans ; Methylphenidate/therapeutic use ; Attention Deficit Disorder with Hyperactivity/drug therapy ; World Health Organization
    Chemical Substances Methylphenidate (207ZZ9QZ49)
    Language English
    Publishing date 2023-09-20
    Publishing country England
    Document type Letter ; Comment
    ISSN 2215-0374
    ISSN (online) 2215-0374
    DOI 10.1016/S2215-0366(23)00292-4
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  10. Article: Beyond the pill: new medication delivery options for ADHD.

    Cutler, Andrew J / Mattingly, Gregory W

    CNS spectrums

    2017  Volume 22, Issue 6, Page(s) 463–474

    Abstract: Successful treatment of pediatric disorders has necessitated the development of alternative medication formulations, as children may prefer alternative dosage forms to tablets or capsules. This is especially true for attention-deficit/hyperactivity ... ...

    Abstract Successful treatment of pediatric disorders has necessitated the development of alternative medication formulations, as children may prefer alternative dosage forms to tablets or capsules. This is especially true for attention-deficit/hyperactivity disorder (ADHD), which is one of the most common chronic pediatric conditions and often involves children with a variety of overlapping physical, psychological, or neurodevelopmental disorders. A special challenge for developing alternative dosage forms for ADHD treatment is the incorporation of a once-daily long-acting formulation. Traditional ADHD medication formulations have been limited, and issues surrounding prescribed dosing regimens-including poor medication adherence, difficulty swallowing, and the lack of dosing titration options-persist in ADHD treatment. In other disease areas, the development of alternative formulations has provided options for patients who have issues with consuming solid dosage forms, particularly children and individuals with developmental disorders. In the light of these new developments, several alternative formulations for ADHD medications are under development or have recently become available. This article reviews the various strategies for developing alternative dosage forms in other disease areas and discusses the application of these strategies in ADHD treatment. Alternative dosage forms may increase medication adherence, compliance, and patient preference and, therefore, improve the overall treatment for ADHD.
    MeSH term(s) Attention Deficit Disorder with Hyperactivity/drug therapy ; Central Nervous System Stimulants/administration & dosage ; Dosage Forms ; Humans
    Chemical Substances Central Nervous System Stimulants ; Dosage Forms
    Language English
    Publishing date 2017-07-07
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2008418-3
    ISSN 2165-6509 ; 1092-8529
    ISSN (online) 2165-6509
    ISSN 1092-8529
    DOI 10.1017/S1092852916000936
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