611 research outputs found
sj-docx-1-jpx-10.1177_23743735211052737 - Supplemental material for Telehealth use and Satisfaction among U.S. Households: Results of a National Survey
No full textSupplemental material, sj-docx-1-jpx-10.1177_23743735211052737 for Telehealth use and Satisfaction among U.S. Households: Results of a National Survey by Michael A Kyle, Robert J Blendon, Mary G Findling and John M Benson in Journal of Patient Experience</p
Supplemental_Table_1 – Supplemental material for A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD
No full textSupplemental material, Supplemental_Table_1 for A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD by Janet K. Johnson, Tesfaye Liranso, Keith Saylor, Gabriela Tulloch, Toyin Adewole, Stefan Schwabe, Azmi Nasser, Robert L. Findling and Jeffrey H. Newcorn in Journal of Attention Disorders</p
Book Review: "Clinical Manual for Management of Bipolar Disorder in Children and Adolescents"
No full textBook review of Clinical Manual for Management of Bipolar Disorder in Children and Adolescents. Edited by Robert A. Kowatch, M.D., Ph.D., Mary A. Fristad, Ph.D., A.B.P.P., Robert L. Findling, M.D., and Robert M. Post, M.D.; Arlington, Virginia, American Psychiatric Publishing, 2009, 355 pages, $59
The safety and effectiveness of open-label extended-release carbamazepine in the treatment of children and adolescents with bipolar I disorder suffering from a manic or mixed episode
No full textRobert L Findling,1,2 Lawrence D Ginsberg31Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, 2Kennedy Krieger Institute, Baltimore, MD, USA; 3Red Oak Psychiatry Associates, PA, Houston, TX, USAObjective: To assess the safety and effectiveness of open-label treatment with extended-release carbamazepine (ERC) in pediatric subjects suffering from bipolar I disorder.Method: Medically healthy youths aged 10–17 years suffering from an acute manic or mixed episode were eligible. After screening for study eligibility, the youths began a 5-week titration period in which doses of ERC were adjusted in order to optimize benefit whilst minimizing adverse events, at doses between 200–1,200 mg/day. Thereafter, subjects could continue to receive treatment during a subsequent 21-week period. Safety measures included spontaneously reported adverse events (AEs) and laboratory assessments. The primary efficacy measure was the Young Mania Rating Scale (YMRS).Results: A total of 60 children (ages 10–12) and 97 adolescents (ages 13–17), with an overall average age of 13.4 years (standard deviation [SD] 2.0 years) received ERC. The mean duration of study participation was 109.6 days (SD 70.2 days), with 66 (42%) completing the entire study. At end of study participation (end point), the most prevalent dose of ERC was 1,200 mg: 31.7% of children and 24.7% of adolescents reached the 1,200 mg dose. The YMRS decreased from a mean of 28.6 (SD 6.2) at baseline to a mean of 13.8 (SD 9.4) (P<0.0001) at end point. A total of 26 subjects discontinued study participation because of AEs, the most common of which were rash (n=6), white blood cell count decreased (n=5), nausea (n=3), and vomiting (n=3). No deaths were reported. The most commonly reported AEs were headache (n=41), somnolence (n=30), nausea (n=22), dizziness (n=21), and fatigue (n=19).Conclusions: Open-label administration of ERC might be a safe and effective intervention in this subject population. More definitive studies are warranted.Keywords: bipolar disorder, children, adolescents, treatment, carbamazepin
Population pharmacokinetics of methylphenidate hydrochloride extended-release multiple-layer beads in pediatric subjects with attention deficit hyperactivity disorder
No full textNathan S Teuscher,1 Akwete Adjei,2 Robert L Findling,3,4 Laurence L Greenhill,5 Robert J Kupper,2 Sharon Wigal6 1PK/PD Associates, Trophy Club, TX, 2Rhodes Pharmaceuticals L.P., Coventry, RI, 3Department of Psychiatric Services and Research, Kennedy Krieger Institute, Baltimore, MD, 4Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, 5Department of Psychiatry, Division of Child and Adolescent Psychiatry, New York State Psychiatric Institute, Columbia University, New York, NY, 6AVIDA Inc., Newport Beach, CA, USA Abstract: A new multilayer-bead formulation of extended-release methylphenidate hydrochloride (MPH-MLR) has been evaluated in pharmacokinetic studies in healthy adults and in Phase III efficacy/safety studies in children and adolescents with attention deficit hyperactivity disorder (ADHD). Using available data in healthy adults, a two-input, one-compartment, first-order elimination population pharmacokinetic model was developed using nonlinear mixed-effect modeling. The model was then extended to pediatric subjects, and was found to adequately describe plasma concentration–time data for this population. A pharmacokinetic/pharmacodynamic model was also developed using change from baseline in the ADHD Rating Scale (ADHD-RS)-IV total scores from a pediatric Phase III trial and simulated plasma concentration–time data. During simulations for each MPH-MLR dose level (10–80 mg), increased body weight resulted in decreased maximum concentration. Additionally, as maximum concentration increased, ADHD-RS-IV total score improved (decreased). Knowledge of the relationship between dose, body weight, and clinical response following the administration of MPH-MLR in children and adolescents may be useful for clinicians selecting initial dosing of MPH-MLR. Additional study is needed to confirm these results. Keywords: population pharmacokinetics, Aptensio XR™, MPH-MLR, methylphenidat
Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study
No full textObjective: To evaluate the efficacy and safety of vortioxetine in adolescents with major depressive disorder (MDD). Method: After 4 weeks of single-blind lead-in treatment with a Brief Psychosocial Intervention (BPI) plus placebo, patients (aged 12-17 years) with MDD (DSM-5) who did not meet response criteria (Children's Depression Rating Scale - Revised [CDRS-R]; total score ≥40 plus <40% reduction and a Parent Global Assessment score >2) were randomized 1:1:1:1 to 8 weeks of BPI plus double-blind treatment with vortioxetine 10 mg, vortioxetine 20 mg, fluoxetine 20 mg, or placebo. The primary endpoint was change from randomization in CDRS-R total score at week 8; primary comparison was the average effect of 2 vortioxetine doses versus placebo. Results: Of 784 patients enrolled in the lead-in, 616 were randomized. At week 8, mean change in CDRS-R total score averaged for vortioxetine doses was -18.01 (standard error = 0.98) and mean difference versus placebo was 0.21 (P = .878; not significant). For fluoxetine, mean change in CDRS-R total score was -21.95 and mean difference versus placebo was -3.73 (P = .015). Treatment-emergent adverse events occurring in ≥5% of patients in either vortioxetine arm and at least twice more frequently than placebo were nausea, headache, vomiting, and dizziness. Conclusion: Patients in all groups showed reduction in CDRS-R scores by end of study, with no difference between combined doses of vortioxetine and placebo. The primary endpoint was not met, thereby rendering the study negative. The overall favorable safety profile of vortioxetine in an adolescent patient population was consistent with that seen in adults. Clinical trial registration information: Active Reference (Fluoxetine) Fixed-Dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD); http://clinicaltrials.gov; NCT02709746
27.1 Levomilnacipran: A Review of Its Biodisposition and Efficacy in Major Depressive Disorder
No full textReplicating and extending the reliability, criterion validity, and treatment sensitivity of the shortened PANSS for pediatric trials
No full textDo the shortened Positive and Negative Syndrome Scale (PANSS) (Kay et al., J Clin Psychiatry 58:538-546, 1987) versions recently developed from a National Institute of Mental Health (NIMH) pediatric dataset continue to perform well in a third independent randomized double-blind clinical trial of adolescents with schizophrenia? Secondary analysis of the double-blind, placebo-controlled aripiprazole pivotal trial data (N = 302) found that the 10-item (and 20-item) PANSS versions on which we have previously reported (Findling et al., J Am Acad Child Adolesc Psychiatry, https://doi.org/10.1016/j.jaac.2022.07.864 , 2023) continued to provide high reliability, strong convergent correlation with expected measures, and treatment effects that equaled those found in the 30-item adult PANSS. Our shortened PANSS, derived originally from the randomized non-placebo controlled NIMH Treatment of Early Onset Schizophrenia Spectrum study (TEOSS) (Sikich et al., Am J Psychiatry 165(11):1420-1431, 2008), and independently replicated in both the placebo-controlled paliperidone pivotal trial for adolescents with schizophrenia (Youngstrom et al., PsyArxiv, https://doi.org/10.31234/osf.io/zb695 , 2023), and now the placebo-controlled aripiprazole pivotal trial for adolescents with schizophrenia, has again performed as well as the full 30 item adult-patient derived PANSS. The findings suggest it is possible to reduce the PANSS interview by 2 thirds, thus reducing burden on families and pediatric patients as well as administration and training costs, while maintaining high reliability, validity, and sensitivity to treatment equal to that of the 30-item version
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