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2. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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6. Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant

Author

Hudgens, Stacie, Floden, Lysbeth, Blackowicz, Michael, Jamieson, Carol, Popova, Vanina, Fedgchin, Maggie, Drevets, Wayne C., Cooper, Kimberly, Lane, Rosanne, and Singh, Jaskaran

Published
2021
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7. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Koenig, Franz, primary, Spiertz, Cécile, additional, Millar, Daniel, additional, Rodríguez-Navarro, Sarai, additional, Machín, Núria, additional, Van Dessel, Ann, additional, Genescà, Joan, additional, Pericàs, Juan M., additional, Posch, Martin, additional, Sánchez-Montalva, Adrian, additional, Estevez, Ana Belén, additional, Sánchez, Àlex, additional, Sanjuan, Anna, additional, Sena, Elena, additional, Granados, Emma, additional, Arévalo de Andrés, Esther, additional, Nuñez, Fátima, additional, Arteaga, Gara, additional, Fuentes Ruiz, Gabriela Perez, additional, Fernández, Guillermo, additional, Rivera-Esteban, Jesus, additional, Comella, Joan, additional, Ramos-Quiroga, Josep Antoni, additional, Espinosa, Juan, additional, Pericàs, Juan Manuel, additional, Murcia, Lada, additional, Cash-Gibson, Lucinda, additional, de Valles Silvosa, Maria, additional, Barroso de Sousa, María Fernanda, additional, Sánchez-Maroto Carrizo, Olga, additional, Ibañez-Jiménez, Pol, additional, Augustin, Salvador, additional, Perez-Hoyos, Santiago, additional, Muñoz-Martínez, Sergio, additional, Serres, Silvia, additional, Kalko, Susana, additional, Michon, Amelie, additional, Ussi, Anton, additional, Lydall, Ben, additional, van de Ketterij, Edwin, additional, Quiles, Ignacio, additional, Carapina, Tamara, additional, Kumaus, Constantin, additional, Ramazanova, Dariga, additional, Meyer, Elias Laurin, additional, Koenig, Franz, additional, Roig, Marta Bofill, additional, Brunner, Martin, additional, Krotka, Pavla, additional, Zehetmayer, Sonja, additional, Carton, Charlotte, additional, Legius, Eric, additional, Begum, Amina, additional, Pariante, Carmine, additional, Worrell, Courtney, additional, Lombardo, Giulia, additional, Sforzini, Luca, additional, Brown, Mollie, additional, Gullet, Nancy, additional, Amasi-Hartoonian, Nare, additional, Ferner, Rosalie, additional, Kose, Melisa, additional, Spitaleri, Andrea, additional, Ghodousi, Arash, additional, Di Serio, Clelia, additional, Cirillo, Daniela, additional, Cugnata, Federica, additional, Saluzzo, Francesca, additional, Benedetti, Francesco, additional, Scarale, Maria Giovanna, additional, Zini, Michela, additional, Rancoita, Paola Maria, additional, Alagna, Riccardo, additional, Poletti, Sara, additional, Dhaenens, Britt, additional, Van Der Lei, Johan, additional, de Steenwinkel, Jurriaan, additional, Moinat, Maxim, additional, Oostenbrink, Rianne, additional, Hoogendijk, Witte, additional, Hölscher, Michael, additional, Heinrich, Norbert, additional, Otte, Christian, additional, Potratz, Cornelia, additional, Zocholl, Dario, additional, Kulakova, Eugenia, additional, Tacke, Frank, additional, Brasanac, Jelena, additional, Leubner, Jonas, additional, Krajewska, Maja, additional, Freitag, Michaela Maria, additional, Gold, Stefan, additional, Zoller, Thomas, additional, Chae, Woo Ri, additional, Daniel, Christel, additional, Kara, Leila, additional, Vaterkowski, Morgan, additional, Griffon, Nicolas, additional, Wolkenstein, Pierre, additional, Pais, Raluca, additional, Ratziu, Vlad, additional, Voets, David, additional, Maes, Christophe, additional, Kalra, Dipak, additional, Thienpoint, Geert, additional, Deckerck, Jens, additional, Lea, Nathan, additional, Singleton, Peter, additional, Viele, Kert, additional, Jacko, Peter, additional, Berry, Scott, additional, Parke, Tom, additional, Aydin, Burç, additional, Kubiak, Christine, additional, Demotes, Jacques, additional, Ueda, Keiko, additional, Matei, Mihaela, additional, Contrino, Sergio, additional, Röhl, Claas, additional, Cordero, Estefania, additional, Greenhalgh, Fiona, additional, Jarke, Hannes, additional, Angelova, Juliana, additional, Boudes, Mathieu, additional, Dressler, Stephan, additional, Strammiello, Valentina, additional, Anstee, Quentin, additional, Gutierrez-Ibarluzea, Iñaki, additional, Otte, Maximilian, additional, Heimbach, Natalie, additional, Hofner, Benjamin, additional, Burgwinkel, Cora, additional, Kaestel, Hue, additional, Hees, Katharina, additional, Nguyen, Quynh, additional, Prieto-Alhambra, Daniel, additional, Tan, Eng Hooi (Cheryl), additional, Raviglione, Mario, additional, de Colombani, Pierpaolo, additional, Villa, Simone, additional, Maron, Eduard, additional, Evans, Gareth, additional, Savitz, Adam J., additional, Duca, Anna, additional, Kaminski, Anne, additional, Wouters, Bie, additional, Porter, Brandon, additional, Charron, Catherine, additional, Spiertz, Cecile, additional, Zizzamia, Christopher, additional, Hasselbaink, Danny, additional, Orr, David, additional, Kesters, Divya, additional, Hubin, Ellen, additional, Davies, Emma, additional, Didden, Eva-Maria, additional, Guz, Gabriela, additional, Verstraete, Evelyn, additional, Mao, Gary, additional, Capuano, George, additional, Martynowicz, Heddie, additional, De Smedt, Heidi, additional, Larsson, Ingela, additional, Bruegelmans, Ines, additional, Coste, Isabelle, additional, Gonzalez Moreno, Jesus Maria, additional, Niewczas, Julia, additional, Xu, Jiajun, additional, Rombouts, Karin, additional, Woo, Katherine, additional, Wuyts, Kathleen, additional, Hersh, Kathryn, additional, Oldenburg, Khrista, additional, Zhang, Lingjiao, additional, Schmidt, Mark, additional, Szuch, Mark, additional, Todorovic, Marija, additional, Mangelaars, Maartje, additional, Grewal, Melissa, additional, Sandor, Molli, additional, Di Prospero, Nick, additional, Van Houten, Pamela, additional, Minnick, Pansy, additional, Bastos, Polyana, additional, Patrizi, Robert, additional, Morello, Salvatore, additional, De Wilde, Severijn, additional, Sun, Tao, additional, Kline, Timothy, additional, de Marez, Tine, additional, Mielke, Tobias, additional, Reijns, Tom, additional, Popova, Vanina, additional, Flossbach, Yanina, additional, Tymofyeyev, Yevgen, additional, De Groote, Zeger, additional, Sverdlov, Alex, additional, Bobirca, Alexandra, additional, Krause, Annekatrin, additional, Bobrica, Catalin, additional, Heintz, Daniela, additional, Magirr, Dominic, additional, Glimm, Ekkehard, additional, Baffert, Fabienne, additional, Castiglione, Federica, additional, Caruso, Franca, additional, Patalano, Francesco, additional, Bretz, Frank, additional, Heimann, Guenter, additional, Carbarns, Ian, additional, Rodríguez, Ignacio, additional, Ratescu, Ioana, additional, Hampson, Lisa, additional, Pedrosa, Marcos, additional, Hark, Mareile, additional, Mesenbrink, Peter, additional, Penna, Sabina Hernandez, additional, Bergues-Lang, Sarah, additional, Baltes-Engler, Susanne, additional, Arsiwala, Tasneem, additional, Mondragon, Valeria Jordan, additional, Guo, Hua, additional, Da Costa, Jose Leite, additional, Burman, Carl-Fredrik, additional, Kirk, George, additional, Aaes-Jørgensen, Anders, additional, Dirach, Jorgen, additional, Kjær, Mette Skalshøi, additional, Martin, Alexandra, additional, Hristov, Diyan, additional, Rousseaux, Florent, additional, Hittel, Norbert, additional, Dornheim, Robert, additional, Evans, Daniel, additional, Sykes, Nick, additional, Couvert, Camille, additional, Leuven, Catherine, additional, Notelet, Loïc, additional, Gidh-Jain, Madhavi, additional, Jouannin, Mathieu, additional, Ammour, Nadir, additional, Pierre, Suzanne, additional, Haufe, Volker, additional, Dong, Yingwen, additional, Dubanchet, Catherine, additional, de Préville, Nathalie, additional, Baltauss, Tania, additional, Jian, Zhu, additional, Shnider, Sara, additional, Bar-El, Tal, additional, Bakker, Annette, additional, Nievo, Marco, additional, Iloeje, Uche, additional, Conradie, Almari, additional, Auffarrth, Ece, additional, Lombard, Leandra, additional, Benhayoun, Majda, additional, Olugbosi, Morounfolu, additional, Seidel, Stephanie S., additional, Gumí, Berta, additional, Guzmán, Claudia García, additional, Molero, Eva, additional, Pairó, Gisela, additional, Machin, Núria, additional, Cardelús, Raimon, additional, Ramasastry, Saira, additional, Pelzer, Saskia, additional, Kremer, Andreas, additional, Lindfors, Erno, additional, and Lynch, Chris, additional

Published
2024
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11. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study

Author

Zaki, Naim, primary, Chen, Li, additional, Lane, Rosanne, additional, Doherty, Teodora, additional, Drevets, Wayne C., additional, Morrison, Randall L., additional, Sanacora, Gerard, additional, Wilkinson, Samuel T., additional, Popova, Vanina, additional, and Fu, Dong-Jing, additional

Published
2023
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13. A Meta-Analysis of the Antidepressant Responses in Pivotal Trials on Esketamine Nasal Spray and Atypical Antipsychotics

Author

Wang,Lien, Chen,Xiaowei, Gu,Xiaojing, De Smedt,Heidi, Popova,Vanina, Fu,Dong-Jing, Canuso,Carla, Drevets,Wayne, Chen,Guang, Wang,Lien, Chen,Xiaowei, Gu,Xiaojing, De Smedt,Heidi, Popova,Vanina, Fu,Dong-Jing, Canuso,Carla, Drevets,Wayne, and Chen,Guang

Abstract

Lien Wang,1,2 Xiaowei Chen,1 Xiaojing Gu,1 Heidi De Smedt,3 Vanina Popova,3 Dong-Jing Fu,4 Carla M Canuso,4 Wayne C Drevets,2 Guang Chen2 1Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Shanghai, People’s Republic of China; 2Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Brisbane, CA, USA; 3Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium; 4Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ, USACorrespondence: Guang Chen, Janssen Fellow, Scientific Director, Translational Research, Mood DAS, Neuroscience Therapeutic Area, Janssen R & D, LLC, Janssen Pharmaceutical Companies of Johnson and Johnson, 3210 Merryfield Row, Room 1908, San Diego, CA, 92121, USA, Tel +1 (240) 602 7950, Email guangchenmd@gmail.comPurpose: This meta-analysis assessed whether atypical antipsychotics (AAPs) and esketamine nasal spray (ESK-NS), which are mechanistically distinct, differ in antidepressant outcomes.Patients and Methods: Data were extracted from 12 trials of ESK-NS or AAPs in depressed patients (4276) with inadequate response or resistance to conventional antidepressants. Montgomery-Åsberg Depression Rating Scale (MADRS) score reductions from baseline and response rates (≥ 50% reduction) were analyzed.Results: At endpoint, the estimated MADRS score reduction of pooled ESK-NS arms was greater than pooled AAP arms (+9.16 points, p < 0.0001). The reduction also was greater in the pooled control arms of the ESK-NS trials than the pooled control arms of the AAP trials (+7.57 points, p < 0.0001). The mean difference in the reductions between pooled ESK-NS and control arms was 1.87 points greater than that between pooled AAP and control arms, but this difference was not significant (95% CI: − 4.49, 0.74, p = 0.16). Relative to their respectiv

Published
2023

16. Use of Clinical Global Impressions-Severity (CGI-S) to Assess Response to Antidepressant Treatment in Patients with Treatment-Resistant Depression

Author

Morrens,Joachim, Mathews,Maju, Popova,Vanina, Borentain,Stephane, Rive,Benoit, Gonzalez Martin Moro,Beatriz, Jamieson,Carol, Zhang,Qiaoyi, Morrens,Joachim, Mathews,Maju, Popova,Vanina, Borentain,Stephane, Rive,Benoit, Gonzalez Martin Moro,Beatriz, Jamieson,Carol, and Zhang,Qiaoyi

Abstract

Joachim Morrens,1 Maju Mathews,2 Vanina Popova,1 Stephane Borentain,2 Benoit Rive,3 Beatriz Gonzalez Martin Moro,4 Carol Jamieson,5 Qiaoyi Zhang2 1Janssen Research & Development, Beerse, Belgium; 2Janssen Global Services, LLC, Titusville, NJ, USA; 3Janssen-Cilag, Paris, France; 4Janssen-Cilag, Madrid, Spain; 5Janssen Research & Development, LLC, Milpitas, CA, USACorrespondence: Qiaoyi Zhang, Janssen Global Services, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA, Tel +1 908 300 2500, Email qzhang87@its.jnj.comBackground: This post-hoc analysis evaluated the agreement between Clinical Global Impressions-Severity (CGI-S) score- and Montgomery–Åsberg Depression Rating Scale (MADRS) total score-based assessment of response in patients with treatment-resistant depression (TRD) treated with esketamine nasal spray plus a newly initiated oral antidepressant (ESK-NS + AD).Methods: Data were analyzed from a phase 3, randomized, double-blind study (TRANSFORM-2) of flexibly dosed esketamine or placebo nasal spray plus a newly initiated oral-AD in adults with moderate-to-severe TRD. Patients with ≥ 50% reduction in MADRS from baseline at the end of the 4-week acute treatment phase were defined as responders. For the CGI-S-based assessment of response, patients with ≥ 2 points decrease from baseline or a CGI-S score of ≤ 3 (mildly depressed to normal) were considered responders. Cohen’s kappa coefficient was calculated to assess level of agreement between MADRS and CGI-S-based assessments.Results: At the end of 4-week treatment, the proportion of responders among all study patients (n=201) was similar when assessed using the MADRS (61%) and CGI-S (62%) methods, with substantial agreement (Cohen’s kappa=0.76; sensitivity=92%; specificity=84%) between both methods. When restricting analysis to ESK-NS + AD-treated patients (n=101) who had a higher response rate (on MADRS: 69%; on CGI-S: 68%), the agreement remained substantial (Cohen’s kappa=0.7

Published
2022

17. Montgomery‐Åsberg Depression Rating Scale factors in treatment‐resistant depression at onset of treatment: Derivation, replication, and change over time during treatment with esketamine

Author

Borentain, Stephane, primary, Gogate, Jagadish, additional, Williamson, David, additional, Carmody, Thomas, additional, Trivedi, Madhukar, additional, Jamieson, Carol, additional, Cabrera, Patricia, additional, Popova, Vanina, additional, Wajs, Ewa, additional, DiBernardo, Allitia, additional, and Daly, Ella J., additional

Published
2022
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19. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression

Author

Chen, Guang, primary, Chen, Li, additional, Zhang, Yun, additional, Li, Xiang, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Daly, Ella J, additional, Furey, Maura L, additional, Fedgchin, Maggie, additional, Popova, Vanina, additional, Singh, Jaskaran B, additional, and Drevets, Wayne C, additional

Published
2022
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22. Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials

Author

Borentain,Stephane, Williamson,David, Turkoz,Ibrahim, Popova,Vanina, McCall,William V, Mathews,Maju, Wiegand,Frank, Borentain,Stephane, Williamson,David, Turkoz,Ibrahim, Popova,Vanina, McCall,William V, Mathews,Maju, and Wiegand,Frank

Abstract

Stephane Borentain,1 David Williamson,2,3 Ibrahim Turkoz,4 Vanina Popova,5 William V McCall,3 Maju Mathews,1 Frank Wiegand1 1Department of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2CNS Scientific Affairs Liaisons, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA; 4Department of Clinical Statistics, Janssen Research & Development, LLC, Titusville, NJ, USA; 5Department of Neuroscience Clinical Development, Janssen Research & Development, Beerse, BelgiumCorrespondence: Stephane BorentainDepartment of Global Medical Affairs, Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USATel +1 609-7304420Email SBorent1@ITS.JNJ.comPurpose: To evaluate the relationship of sleep disturbance to the antidepressant effects of esketamine.Materials and Methods: Two double-blind, 4-week studies randomized adults with treatment-resistant depression (TRD) to placebo or esketamine nasal spray, each with newly initiated antidepressant. Sleep was assessed using Montgomery–Åsberg Depression Rating Scale (MADRS) item 4. Change in response (≥ 50% decrease in MADRS total score) and remission (total MADRS score ≤ 12) at day 28 was examined by presence/absence of baseline sleep disturbance using logistic regression models. Impact on reported sleep disturbance (MADRS item 4 score) was examined using ANCOVA models.Results: At baseline, most patients reported disturbed sleep – moderate/severe (65.3%, 369/565), mild (25.3%, 143/565), or none/slightly (9.4%, 53/565) – with similar distribution between treatment groups. A higher proportion of esketamine-treated patients achieved response (OR = 2.05; 95% CI: 1.40– 3.02; P < 0.001) and remission (OR = 1.81; 95% CI: 1.23– 2.66; P = 0.003) at day 28 compared to antidepressant plus placebo, regardless of presence/severity of sleep d

Published
2021

31. Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study

Author

Popova, Vanina, primary, Daly, Ella J., additional, Trivedi, Madhukar, additional, Cooper, Kimberly, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Mazzucco, Christine, additional, Hough, David, additional, Thase, Michael E., additional, Shelton, Richard C., additional, Molero, Patricio, additional, Vieta, Eduard, additional, Bajbouj, Malek, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, and Singh, Jaskaran B., additional

Published
2019
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32. S111. Randomized, Double-Blind Study of Flexibly-Dosed Intranasal Esketamine Plus Oral Antidepressant Vs. Active Control in Treatment-Resistant Depression

Author

Popova, Vanina, primary, Daly, Ella, additional, Trivedi, Madhukar, additional, Cooper, Kimberly, additional, Lane, Roseanne, additional, Lim, Pilar, additional, Mazzucco, Christine, additional, Hough, David, additional, Thase, Michael, additional, Shelton, Richard, additional, Molero, Patricio, additional, Vieta, Eduard, additional, Bajbouj, Malek, additional, Manji, Husseini, additional, Drevets, Wayne, additional, and Singh, Jaskaran, additional

Published
2018
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33. Comments to Drs. Gastaldon, Raschi, Kane, Barbui, and Schoretsanitis.

Author

Doherty, Teodora, Daly, Ella J., Miller, Janice, Popova, Vanina, Cepeda, M. Soledad, Drevets, Wayne C., and Canuso, Carla M.

Subjects
DRUG side effects, SUICIDE risk factors
Abstract

Janssen remains committed to ongoing esketamine safety monitoring via robust risk management and pharmacovigilance surveillance programs, including REMS, to ensure that up-to-date safety information is available to prescribers and patients. Moreover, as required by the FDA, Janssen follows an ongoing Risk Evaluation and Mitigation Strategy (REMS) [[2]] to mitigate potential risks of serious adverse outcomes associated with sedation, dissociation, and misuse/abuse of esketamine. Janssen recognizes esketamine's unique safety profile and is committed to continuous assessment of postmarketing safety data through comprehensive pharmacovigilance surveillance from multiple sources, including FAERS. [Extracted from the article]

Published
2021
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