Search Results - "Youakim, James M"

Trofinetide for the treatment of Rett syndrome: a randomized phase 3 study by Neul, Jeffrey L., Percy, Alan K., Benke, Timothy A., Berry-Kravis, Elizabeth M., Glaze, Daniel G., Marsh, Eric D., Lin, Tim, Stankovic, Serge, Bishop, Kathie M., Youakim, James M.

“…Rett syndrome is a rare, genetic neurodevelopmental disorder. Trofinetide is a synthetic analog of glycine–proline–glutamate, the N-terminal tripeptide of the…”
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Revisiting Criteria for Psychosis in Alzheimer's Disease and Related Dementias: Toward Better Phenotypic Classification and Biomarker Research by Fischer, Corinne E, Ismail, Zahinoor, Youakim, James M, Creese, Byron, Kumar, Sanjeev, Nuñez, Nicolas, Ryan Darby, R, Di Vita, Antonella, D'Antonio, Fabrizia, de Lena, Carlo, McGeown, William J, Ramit, Ravona, Rasmussen, Jill, Bell, Joanne, Wang, Huali, Bruneau, Marie-Andrée, Panegyres, Peter K, Lanctôt, Krista L, Agüera-Ortiz, Luis, Lyketsos, Constantine, Cummings, Jeffrey, Jeste, Dilip V, Sano, Mary, Devanand, D P, Sweet, Robert A, Ballard, Clive

“…Psychotic symptoms are common in Alzheimer's disease (AD) and related neurodegenerative disorders and are associated with more rapid disease progression and…”
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Development of trofinetide for the treatment of Rett syndrome: from bench to bedside by Kennedy, Melissa, Glass, Larry, Glaze, Daniel G, Kaminsky, Steve, Percy, Alan K, Neul, Jeffrey L, Jones, Nancy E, Tropea, Daniela, Horrigan, Joseph P, Nues, Paige, Bishop, Kathie M, Youakim, James M

“…Rett syndrome (RTT) is rare neurodevelopmental disorder caused by mutations in the gene that encodes methyl-CpG-binding protein 2 (MeCP2), a DNA-binding…”
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Gastrointestinal manifestations in pediatric and adult patients with Rett syndrome: an analysis of US claims and physician survey data by May, Damian M, Neul, Jeffrey, Piña-Garza, Jesús Eric, Kponee-Shovein, Kalé, Satija, Ambika, Mahendran, Malena, Downes, Nathaniel, Sheng, Kristy, Lema, Neema, Boca, Andra, Lefebvre, Patrick, Abler, Victor, Youakim, James M, Cheng, Wendy Y

“…Patients with Rett syndrome (RTT) experience gastrointestinal (GI) manifestations. This study aimed to describe the prevalence of GI manifestations and the…”
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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Armodafinil for Excessive Sleepiness Associated With Jet Lag Disorder by Rosenberg, Russell P., PhD, Bogan, Richard K., MD, Tiller, Jane M., FRCPsych, Yang, Ronghua, PhD, Youakim, James M., MD, Earl, Craig Q., PhD, Roth, Thomas, PhD

“…OBJECTIVE To assess the effect of armodafinil, the longer-lasting isomer of modafinil, on jet lag disorder. PARTICIPANTS AND METHODS This double-blind,…”
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Trial of Pimavanserin in Dementia-Related Psychosis by Tariot, Pierre N, Cummings, Jeffrey L, Soto-Martin, Maria E, Ballard, Clive, Erten-Lyons, Deniz, Sultzer, David L, Devanand, Davangere P, Weintraub, Daniel, McEvoy, Bradley, Youakim, James M, Stankovic, Srdjan, Foff, Erin P

“…The serotonin-receptor modulator pimavanserin reduces psychosis in patients with Parkinson’s disease. In a randomized discontinuation trial involving patients…”
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Efficacy and safety of adjunctive brexpiprazole 2 mg in major depressive disorder: a phase 3, randomized, placebo-controlled study in patients with inadequate response to antidepressants by Thase, Michael E, Youakim, James M, Skuban, Aleksandar, Hobart, Mary, Augustine, Carole, Zhang, Peter, McQuade, Robert D, Carson, William H, Nyilas, Margaretta, Sanchez, Raymond, Eriksson, Hans

“…To assess the efficacy, tolerability, and safety of brexpiprazole as adjunctive therapy to antidepressant treatments (ADTs) in adults with major depressive…”
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Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study by Ballard, Clive, Banister, Carol, Khan, Zunera, Cummings, Jeffrey, Demos, George, Coate, Bruce, Youakim, James M, Owen, Randall, Stankovic, Srdjan, Tomkinson, Elaine B, McDermid, Joanne, Ocal, Delik, Testad, Ingelin, Qayyum, Mustabshira A, Kemos', Polychronis, Borejko, Olga, Megalogeni, Maria, Brookes, Ella V, Petrava, Anya, Da Silva, Miguel, Nunez, Kayleigh

“…Pimavanserin is a selective 5-HT2A receptor inverse agonist and antagonist approved in the USA for the treatment of hallucinations and delusions associated…”
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A Physiologically Based Pharmacokinetic Modeling Approach to Assess the Potential for Drug Interactions Between Trofinetide and CYP3A4-Metabolized Drugs by Darwish, Mona, Youakim, James M., Darling, Inger, Lukacova, Viera, Owen, Joel S., Bradley, Heather

“…Trofinetide is the first drug to be approved by the US Food and Drug Administration for use in the treatment of patients with Rett syndrome, a multisystem…”
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Characterization of the Pharmacokinetics and Mass Balance of a Single Oral Dose of Trofinetide in Healthy Male Subjects by Darwish, Mona, Nunez, Rene, Youakim, James M., Robertson, Philmore

“…Background and Objective Trofinetide is the first drug to be approved for the treatment of Rett syndrome, a neurodevelopmental disorder. The purpose of the…”
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A Phase 1, Open-Label Study to Evaluate the Effects of Food and Evening Dosing on the Pharmacokinetics of Oral Trofinetide in Healthy Adult Subjects by Darwish, Mona, Youakim, James M., Harlick, Jim, DeKarske, Daryl, Stankovic, Serge

“…Background and Objective Trofinetide, a synthetic analog of tripeptide glycine-proline-glutamate, is an investigational agent for the treatment of Rett…”
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Adjunctive brexpiprazole 1 and 3 mg for patients with major depressive disorder following inadequate response to antidepressants: a phase 3, randomized, double-blind study by Thase, Michael E, Youakim, James M, Skuban, Aleksandar, Hobart, Mary, Zhang, Peter, McQuade, Robert D, Nyilas, Margaretta, Carson, William H, Sanchez, Raymond, Eriksson, Hans

“…To evaluate efficacy, safety, and tolerability of brexpiprazole adjunctive to antidepressant treatments (ADTs) in patients with major depressive disorder (as…”
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Effect of Hepatic Impairment on Trofinetide Exposures Using an In Silico Physiologically Based Pharmacokinetic Model by Darwish, Mona, Obianom, Obinna N., Youakim, James M., Darling, Inger, Lukacova, Viera, Bradley, Heather

“…Introduction Trofinetide is the first drug to be approved for the treatment of Rett syndrome. Hepatic impairment is not expected to affect the pharmacokinetic…”
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Exposure–Response Efficacy Modeling to Support Trofinetide Dosing in Individuals with Rett Syndrome by Darwish, Mona, Passarell, Julie, Youakim, James M., Bradley, Heather, Bishop, Kathie M.

“…Introduction Trofinetide was recently approved for the treatment of Rett syndrome (RTT) on the basis of the efficacy and safety findings of the phase 3…”
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Design and outcome measures of LAVENDER, a phase 3 study of trofinetide for Rett syndrome by Neul, Jeffrey L., Percy, Alan K., Benke, Timothy A., Berry-Kravis, Elizabeth M., Glaze, Daniel G., Peters, Sarika U., Jones, Nancy E., Youakim, James M.

“…Rett syndrome (RTT) is a debilitating neurodevelopmental disorder with no approved treatments. Trofinetide is a synthetic analog of glycine–proline–glutamate,…”
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Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation by Darwish, Mona, Marbury, Thomas C., Nunez, Rene, Youakim, James M., An, Di, Darling, Inger, Lukacova, Viera, Bishop, Kathie M.

“…Trofinetide, the first approved treatment for Rett syndrome (RTT), is primarily excreted unchanged in the urine; therefore, it is important to assess the…”
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Trofinetide Treatment Demonstrates a Benefit Over Placebo for the Ability to Communicate in Rett Syndrome by Neul, Jeffrey L., Percy, Alan K., Benke, Timothy A., Berry-Kravis, Elizabeth M., Glaze, Daniel G., Peters, Sarika U., Marsh, Eric D., An, Di, Bishop, Kathie M., Youakim, James M.

“…Trofinetide was approved by the US Food and Drug Administration for the treatment of Rett syndrome (RTT) in March 2023. Benefiting the ability to communicate…”
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Identity Transformation in Medical Students by Cohen, Mitchell, J.M., Kay, Abigail, Youakim, James, M., Balaicuis, John, M.

“…This paper reviews the literature on the impact of medical school on personal development and consolidation of core identity. The limited literature relies on…”
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Adjunctive Armodafinil for Major Depressive Episodes Associated With Bipolar I Disorder: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Proof-of-Concept Study by CALABRESE, Joseph R, KETTER, Terence A, YOUAKIM, James M, TILLER, Jane M, RONGHUA YANG, FRYE, Mark A

“…To evaluate the efficacy and safety of armodafinil, the longer-lasting isomer of modafinil, when used adjunctively in patients with bipolar depression. In this…”
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Adjunctive armodafinil for negative symptoms in adults with schizophrenia: A double-blind, placebo-controlled study by Kane, John M, Yang, Ronghua, Youakim, James M

“…Abstract Objective A prior 4-week, proof-of-concept study suggested that adjunctive therapy with armodafinil 200 mg/day decreases negative symptoms in patients…”
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