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Rapid Onset and Sustained Efficacy of Onfasprodil (MIJ821), a Novel NR2B Negative Allosteric Modulator, in Patients With Treatment-Resistant Depression: A Phase 2, Randomized, Placebo-Controlled, Proof-of-Concept Study.

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Title: Rapid Onset and Sustained Efficacy of Onfasprodil (MIJ821), a Novel NR2B Negative Allosteric Modulator, in Patients With Treatment-Resistant Depression: A Phase 2, Randomized, Placebo-Controlled, Proof-of-Concept Study.
Authors: Shelton RC; Department of Psychiatry and Behavioral Neurobiology, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama., Litman RE; Georgetown University Medical School, Washington, DC., Hassman H; Hassman Research Institute, Marlton, New Jersey., Walling DP; Collaborative Neuroscience Network Garden Grove, Garden Grove, California., Ros Montalbán S; Instituto Internacional de Neurociencias Aplicadas Barcelona, Barcelona, Spain., Salvà-Coll J; Hospital Universitari Son Espases, Servicio de Psiquiatría, UIB, IdISBa, Palma de Mallorca, Spain., Zajecka J; Psychiatric Medicine Associates, LLC, Skokie, Illinois., Sverdlov O; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey., Gomez-Mancilla B; Novartis Biomedical Research, Cambridge, Massachusetts.; Novartis Pharma AG, Basel, Switzerland.; McGill University, Montreal, Québec, Canada., Healy MP; Novartis Biomedical Research, Cambridge, Massachusetts.; Corresponding Author: Mark P. Healy, PhD, Global Discovery Chemistry, Novartis Biomedical Research, 22 Windsor St, Cambridge, MA 02478 (mark.healy@novartis.com)., Shanker YG; Novartis Biomedical Research, Cambridge, Massachusetts.; Beam Therapeutics, Cambridge, Massachusetts., Berkheimer M; Novartis Biomedical Research, Cambridge, Massachusetts., Faller T; Novartis Pharma AG, Basel, Switzerland., von Raison F; Novartis Pharma S.A.S., Rueil Malmaison, France., Serban C; Novartis Pharma AG, Basel, Switzerland., Cha JH; Novartis Biomedical Research, Cambridge, Massachusetts., Ghaemi SN; Novartis Biomedical Research, Cambridge, Massachusetts.; Tufts University School of Medicine, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
Source: The Journal of clinical psychiatry [J Clin Psychiatry] 2025 Aug 06; Vol. 86 (3). Date of Electronic Publication: 2025 Aug 06.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase II; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Physicians Postgraduate Press Country of Publication: United States NLM ID: 7801243 Publication Model: Electronic Cited Medium: Internet ISSN: 1555-2101 (Electronic) Linking ISSN: 01606689 NLM ISO Abbreviation: J Clin Psychiatry Subsets: MEDLINE
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  Data: Rapid Onset and Sustained Efficacy of Onfasprodil (MIJ821), a Novel NR2B Negative Allosteric Modulator, in Patients With Treatment-Resistant Depression: A Phase 2, Randomized, Placebo-Controlled, Proof-of-Concept Study.
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  Data: <searchLink fieldCode="AU" term="%22Shelton+RC%22">Shelton RC</searchLink>; Department of Psychiatry and Behavioral Neurobiology, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.<br /><searchLink fieldCode="AU" term="%22Litman+RE%22">Litman RE</searchLink>; Georgetown University Medical School, Washington, DC.<br /><searchLink fieldCode="AU" term="%22Hassman+H%22">Hassman H</searchLink>; Hassman Research Institute, Marlton, New Jersey.<br /><searchLink fieldCode="AU" term="%22Walling+DP%22">Walling DP</searchLink>; Collaborative Neuroscience Network Garden Grove, Garden Grove, California.<br /><searchLink fieldCode="AU" term="%22Ros+Montalbán+S%22">Ros Montalbán S</searchLink>; Instituto Internacional de Neurociencias Aplicadas Barcelona, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Salvà-Coll+J%22">Salvà-Coll J</searchLink>; Hospital Universitari Son Espases, Servicio de Psiquiatría, UIB, IdISBa, Palma de Mallorca, Spain.<br /><searchLink fieldCode="AU" term="%22Zajecka+J%22">Zajecka J</searchLink>; Psychiatric Medicine Associates, LLC, Skokie, Illinois.<br /><searchLink fieldCode="AU" term="%22Sverdlov+O%22">Sverdlov O</searchLink>; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.<br /><searchLink fieldCode="AU" term="%22Gomez-Mancilla+B%22">Gomez-Mancilla B</searchLink>; Novartis Biomedical Research, Cambridge, Massachusetts.; Novartis Pharma AG, Basel, Switzerland.; McGill University, Montreal, Québec, Canada.<br /><searchLink fieldCode="AU" term="%22Healy+MP%22">Healy MP</searchLink>; Novartis Biomedical Research, Cambridge, Massachusetts.; Corresponding Author: Mark P. Healy, PhD, Global Discovery Chemistry, Novartis Biomedical Research, 22 Windsor St, Cambridge, MA 02478 (mark.healy@novartis.com).<br /><searchLink fieldCode="AU" term="%22Shanker+YG%22">Shanker YG</searchLink>; Novartis Biomedical Research, Cambridge, Massachusetts.; Beam Therapeutics, Cambridge, Massachusetts.<br /><searchLink fieldCode="AU" term="%22Berkheimer+M%22">Berkheimer M</searchLink>; Novartis Biomedical Research, Cambridge, Massachusetts.<br /><searchLink fieldCode="AU" term="%22Faller+T%22">Faller T</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22von+Raison+F%22">von Raison F</searchLink>; Novartis Pharma S.A.S., Rueil Malmaison, France.<br /><searchLink fieldCode="AU" term="%22Serban+C%22">Serban C</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Cha+JH%22">Cha JH</searchLink>; Novartis Biomedical Research, Cambridge, Massachusetts.<br /><searchLink fieldCode="AU" term="%22Ghaemi+SN%22">Ghaemi SN</searchLink>; Novartis Biomedical Research, Cambridge, Massachusetts.; Tufts University School of Medicine, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
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  Data: <searchLink fieldCode="JN" term="%227801243%22">The Journal of clinical psychiatry</searchLink> [J Clin Psychiatry] 2025 Aug 06; Vol. 86 (3). <i>Date of Electronic Publication: </i>2025 Aug 06.
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