Page last updated: 2024-10-29

ketamine and Recrudescence

ketamine has been researched along with Recrudescence in 35 studies

Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.
ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group.

Research Excerpts

ExcerptRelevanceReference
"In patients with treatment-resistant depression, esketamine nasal spray plus an SSRI or SNRI was superior to extended-release quetiapine plus an SSRI or SNRI with respect to remission at week 8."9.69Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression. ( Bitter, I; Buyze, J; Cebulla, K; Frey, R; Fu, DJ; Godinov, Y; Ito, T; Kambarov, Y; Llorca, PM; Messer, T; Mulhern-Haughey, S; Oliveira-Maia, AJ; Reif, A; Rive, B; von Holt, C; Young, AH, 2023)
" This trial will provide efficacy, safety and health economic data on serial ketamine infusions and thus help inform clinical practice on the potential role of this treatment in the management of depression."9.69Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2]). ( Igoe, A; Jelovac, A; Loughran, O; McCaffrey, C; McDonagh, K; McDonogh, S; McLoughlin, DM; Mohamed, E; O'Neill, C; Shackleton, E; Shanahan, E; Terao, M; Whooley, E, 2023)
"To determine the diagnosis, treatment, and pathogenesis of ketamine-associated cystitis."8.89[Diagnosis and treatment of ketamine-associated cystitis: a report of 3 cases and literature review]. ( Ding, J; Huang, K; Huang, L; Li, D; Li, Y; Luo, K; Tang, Z; Wang, G; Zhou, J, 2013)
"In this post-hoc analysis, data from 2 positive, pivotal, phase 3 trials of esketamine nasal spray (ESK) in treatment-resistant depression (TRD)-short-term study (TRANSFORM-2) and maintenance study (SUSTAIN-1)-were analyzed to evaluate the relationship between dissociation and antidepressant effects of ESK."8.12Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. ( Chen, G; Chen, L; Daly, EJ; Drevets, WC; Fedgchin, M; Furey, ML; Lane, R; Li, X; Lim, P; Popova, V; Singh, JB; Zhang, Y, 2022)
"The purpose of this study was to report on the efficacy and safety of intravenous ketamine (KE) in refractory convulsive status epilepticus (RCSE) in children and highlight its advantages with particular reference to avoiding endotracheal intubation."7.81Ketamine in refractory convulsive status epilepticus in children avoids endotracheal intubation. ( Guerrini, R; Ilvento, L; L'Erario, M; Marini, C; Mirabile, L; Rosati, A, 2015)
"This case series has described a new clinical entity of severe ulcerative cystitis as a result of chronic ketamine use."7.74Ketamine-associated ulcerative cystitis: a new clinical entity. ( Dickson, B; Shahani, R; Stewart, RJ; Streutker, C, 2007)
"In patients with treatment-resistant depression, esketamine nasal spray plus an SSRI or SNRI was superior to extended-release quetiapine plus an SSRI or SNRI with respect to remission at week 8."5.69Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression. ( Bitter, I; Buyze, J; Cebulla, K; Frey, R; Fu, DJ; Godinov, Y; Ito, T; Kambarov, Y; Llorca, PM; Messer, T; Mulhern-Haughey, S; Oliveira-Maia, AJ; Reif, A; Rive, B; von Holt, C; Young, AH, 2023)
" This trial will provide efficacy, safety and health economic data on serial ketamine infusions and thus help inform clinical practice on the potential role of this treatment in the management of depression."5.69Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2]). ( Igoe, A; Jelovac, A; Loughran, O; McCaffrey, C; McDonagh, K; McDonogh, S; McLoughlin, DM; Mohamed, E; O'Neill, C; Shackleton, E; Shanahan, E; Terao, M; Whooley, E, 2023)
"Ketamine has been extensively studied for its antidepressant potential, with promising results in both preclinical and clinical studies."5.46Differential characteristics of ketamine self-administration in the olfactory bulbectomy model of depression in male rats. ( Babinska, Z; Ruda-Kucerova, J, 2017)
"To determine the diagnosis, treatment, and pathogenesis of ketamine-associated cystitis."4.89[Diagnosis and treatment of ketamine-associated cystitis: a report of 3 cases and literature review]. ( Ding, J; Huang, K; Huang, L; Li, D; Li, Y; Luo, K; Tang, Z; Wang, G; Zhou, J, 2013)
"In this post-hoc analysis, data from 2 positive, pivotal, phase 3 trials of esketamine nasal spray (ESK) in treatment-resistant depression (TRD)-short-term study (TRANSFORM-2) and maintenance study (SUSTAIN-1)-were analyzed to evaluate the relationship between dissociation and antidepressant effects of ESK."4.12Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. ( Chen, G; Chen, L; Daly, EJ; Drevets, WC; Fedgchin, M; Furey, ML; Lane, R; Li, X; Lim, P; Popova, V; Singh, JB; Zhang, Y, 2022)
"The purpose of this study was to report on the efficacy and safety of intravenous ketamine (KE) in refractory convulsive status epilepticus (RCSE) in children and highlight its advantages with particular reference to avoiding endotracheal intubation."3.81Ketamine in refractory convulsive status epilepticus in children avoids endotracheal intubation. ( Guerrini, R; Ilvento, L; L'Erario, M; Marini, C; Mirabile, L; Rosati, A, 2015)
"This case series has described a new clinical entity of severe ulcerative cystitis as a result of chronic ketamine use."3.74Ketamine-associated ulcerative cystitis: a new clinical entity. ( Dickson, B; Shahani, R; Stewart, RJ; Streutker, C, 2007)
"Ketamine has a robust antidepressant effect, but there are no reported studies of ketamine for depression relapse prevention."2.90Ketamine Versus Midazolam for Depression Relapse Prevention Following Successful Electroconvulsive Therapy: A Randomized Controlled Pilot Trial. ( Daly, L; Finnegan, M; Galligan, T; Harkin, A; McLoughlin, DM; Ryan, K; Shanahan, E, 2019)
"Worldwide, alcohol abuse is a burgeoning problem."2.84A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial. ( Brandner, B; Lawn, W; McAndrew, A; Morgan, CJ; Porffy, L; Stevens, T, 2017)
"Ketamine has shown rapid though short-lived antidepressant effects."2.84Cognitive Behavior Therapy May Sustain Antidepressant Effects of Intravenous Ketamine in Treatment-Resistant Depression. ( Fasula, MK; Fenton, L; Griepp, M; Ostroff, RB; Sanacora, G; Wilkinson, ST; Wright, D, 2017)
"This is the first trial to present dose-response data of ketamine efficacy and psychomimetic effects in depressed subjects."2.79Pilot dose-response trial of i.v. ketamine in treatment-resistant depression. ( Glue, P; Harper, S; Katalinic, N; Lai, R; Leyden, J; Loo, CK; Mitchell, PB; Somogyi, AA, 2014)
" A numerical dose-response relationship was observed, with remitters/responders on ketamine 1."1.56Time to relapse after a single administration of intravenous ketamine augmentation in unipolar treatment-resistant depression. ( Cusin, C; Debattista, C; Fava, M; Flynn, M; Freeman, MP; Hock, RS; Hoeppner, B; Ionescu, DF; Iosifescu, DV; Mathew, SJ; Papakostas, GI; Salloum, NC; Sanacora, G; Trivedi, MH, 2020)
"Ketamine has been extensively studied for its antidepressant potential, with promising results in both preclinical and clinical studies."1.46Differential characteristics of ketamine self-administration in the olfactory bulbectomy model of depression in male rats. ( Babinska, Z; Ruda-Kucerova, J, 2017)
"Ketamine is a popular drug of abuse in China, especially for young adults between the 18 and 30 years."1.38Ketamine-induced biliary dilatation: from Hong Kong to New York. ( Gutkin, E; Hussain, SA; Kim, SH, 2012)
"Major depressive disorder is a difficult-to-treat and recurrent debilitating disorder."1.34Rapid relief of severe major depressive disorder by use of preoperative ketamine and electroconvulsive therapy. ( Goforth, HW; Holsinger, T, 2007)
"The long-term follow-up revealed a recurrence before 2 years in 2 hands, between 2 and 4 years in 7 hands and after 4 years in 6 hands."1.30A new protocol for the treatment of hand deformities in recessive dystrophic epidermolysis bullosa (13 cases). ( Campiglio, GL; Pajardi, G; Rafanelli, G, 1997)
"In the CS group, PTAs had a low recurrence rate of 1 (3."1.30Conscious sedation: a new approach for peritonsillar abscess drainage in the pediatric population. ( Lusk, RP; Muntz, HR; Park, J; Piccirillo, JF; Suskind, DL, 1999)

Research

Studies (35)

TimeframeStudies, this research(%)All Research%
pre-19903 (8.57)18.7374
1990's2 (5.71)18.2507
2000's8 (22.86)29.6817
2010's17 (48.57)24.3611
2020's5 (14.29)2.80

Authors

AuthorsStudies
Grabski, M1
McAndrew, A2
Lawn, W2
Marsh, B1
Raymen, L1
Stevens, T2
Hardy, L1
Warren, F1
Bloomfield, M1
Borissova, A1
Maschauer, E1
Broomby, R1
Price, R1
Coathup, R1
Gilhooly, D1
Palmer, E1
Gordon-Williams, R1
Hill, R1
Harris, J1
Mollaahmetoglu, OM1
Curran, HV1
Brandner, B2
Lingford-Hughes, A1
Morgan, CJA1
Chen, G1
Chen, L3
Zhang, Y7
Li, X6
Lane, R1
Lim, P1
Daly, EJ1
Furey, ML1
Fedgchin, M1
Popova, V1
Singh, JB1
Drevets, WC1
Reif, A1
Bitter, I1
Buyze, J1
Cebulla, K1
Frey, R1
Fu, DJ1
Ito, T1
Kambarov, Y1
Llorca, PM1
Oliveira-Maia, AJ1
Messer, T1
Mulhern-Haughey, S1
Rive, B1
von Holt, C1
Young, AH1
Godinov, Y1
Jelovac, A1
McCaffrey, C1
Terao, M1
Shanahan, E2
Mohamed, E1
Whooley, E1
McDonagh, K1
McDonogh, S1
Igoe, A1
Loughran, O1
Shackleton, E1
O'Neill, C1
McLoughlin, DM2
Salloum, NC1
Fava, M1
Hock, RS1
Freeman, MP1
Flynn, M1
Hoeppner, B1
Cusin, C1
Iosifescu, DV1
Trivedi, MH1
Sanacora, G2
Mathew, SJ1
Debattista, C1
Ionescu, DF1
Papakostas, GI1
Hung, CC1
Su, LW1
Yen, MY1
Chuang, P1
Yang, HJ1
Lee, TS1
Halim, AA1
Alsayed, B1
Embarak, S1
Yaseen, T1
Dabbous, S1
Fontaine, O1
Dueluzeau, R1
Raibaud, P1
Chabanet, C1
Popoff, MR1
Badoual, J1
Gabilan, JC1
Andremont, A1
Gómez, L1
Andrés, S1
Sánchez, J1
Alonso, JM1
Rey, J1
López, F1
Jiménez, A1
Yan, Z1
Zhou, L1
Zhao, Y3
Wang, J7
Huang, L3
Hu, K1
Liu, H4
Wang, H3
Guo, Z1
Song, Y1
Huang, H4
Yang, R1
Owen, TW1
Al-Kaysi, RO1
Bardeen, CJ1
Cheng, Q1
Wu, S1
Cheng, T1
Zhou, X1
Wang, B4
Zhang, Q4
Wu, X2
Yao, Y3
Ochiai, T1
Ishiguro, H2
Nakano, R2
Kubota, Y2
Hara, M1
Sunada, K1
Hashimoto, K1
Kajioka, J1
Fujishima, A1
Jiao, J3
Gai, QY3
Wang, W2
Zang, YP2
Niu, LL2
Fu, YJ3
Wang, X4
Yao, LP1
Qin, QP1
Wang, ZY1
Liu, J4
Aleksic Sabo, V1
Knezevic, P1
Borges-Argáez, R1
Chan-Balan, R1
Cetina-Montejo, L1
Ayora-Talavera, G1
Sansores-Peraza, P1
Gómez-Carballo, J1
Cáceres-Farfán, M1
Jang, J1
Akin, D1
Bashir, R1
Yu, Z1
Zhu, J2
Jiang, H1
He, C2
Xiao, Z1
Xu, J2
Sun, Q1
Han, D1
Lei, H1
Zhao, K2
Zhu, L1
Fu, H2
Wilson, BK1
Step, DL1
Maxwell, CL1
Gifford, CA1
Richards, CJ1
Krehbiel, CR1
Warner, JM1
Doerr, AJ1
Erickson, GE1
Guretzky, JA1
Rasby, RJ1
Watson, AK1
Klopfenstein, TJ1
Sun, Y4
Liu, Z3
Pham, TD1
Lee, BK1
Yang, FC1
Wu, KH1
Lin, WP1
Hu, MK1
Lin, L3
Shao, J1
Sun, M1
Xu, G1
Zhang, X6
Xu, N1
Wang, R1
Liu, S1
He, H1
Dong, X2
Yang, M2
Yang, Q1
Duan, S1
Yu, Y2
Han, J2
Zhang, C3
Yang, X1
Li, W3
Wang, T2
Campbell, DA1
Gao, K1
Zager, RA1
Johnson, ACM1
Guillem, A1
Keyser, J1
Singh, B1
Steubl, D1
Schneider, MP1
Meiselbach, H1
Nadal, J1
Schmid, MC1
Saritas, T1
Krane, V1
Sommerer, C1
Baid-Agrawal, S1
Voelkl, J1
Kotsis, F1
Köttgen, A1
Eckardt, KU1
Scherberich, JE1
Li, H4
Yao, L2
Sun, L3
Zhu, Z1
Naren, N1
Zhang, XX2
Gentile, GL1
Rupert, AS1
Carrasco, LI1
Garcia, EM1
Kumar, NG1
Walsh, SW1
Jefferson, KK1
Guest, RL1
Samé Guerra, D1
Wissler, M1
Grimm, J1
Silhavy, TJ1
Lee, JH2
Yoo, JS1
Kim, Y1
Kim, JS2
Lee, EJ1
Roe, JH1
Delorme, M1
Bouchard, PA1
Simon, M1
Simard, S1
Lellouche, F1
D'Urzo, KA1
Mok, F1
D'Urzo, AD1
Koneru, B1
Lopez, G1
Farooqi, A1
Conkrite, KL1
Nguyen, TH1
Macha, SJ1
Modi, A1
Rokita, JL1
Urias, E1
Hindle, A1
Davidson, H1
Mccoy, K1
Nance, J1
Yazdani, V1
Irwin, MS1
Yang, S2
Wheeler, DA1
Maris, JM1
Diskin, SJ1
Reynolds, CP1
Abhilash, L1
Kalliyil, A1
Sheeba, V1
Hartley, AM2
Meunier, B2
Pinotsis, N1
Maréchal, A2
Xu, JY1
Genko, N1
Haraux, F1
Rich, PR1
Kamalanathan, M1
Doyle, SM1
Xu, C1
Achberger, AM1
Wade, TL1
Schwehr, K1
Santschi, PH1
Sylvan, JB1
Quigg, A1
Leong, W1
Xu, W2
Gao, S1
Zhai, X1
Wang, C2
Gilson, E1
Ye, J1
Lu, Y1
Yan, R1
Hu, Z1
You, Q1
Cai, Q1
Yang, D1
Gu, S1
Dai, H1
Zhao, X1
Gui, C1
Gui, J1
Wu, PK1
Hong, SK1
Starenki, D1
Oshima, K1
Shao, H1
Gestwicki, JE1
Tsai, S1
Park, JI1
Wang, Y7
Zhao, R1
Gu, Z1
Dong, C2
Guo, G1
Li, L4
Barrett, HE1
Meester, EJ1
van Gaalen, K1
van der Heiden, K1
Krenning, BJ1
Beekman, FJ1
de Blois, E1
de Swart, J1
Verhagen, HJ1
Maina, T1
Nock, BA1
Norenberg, JP1
de Jong, M1
Gijsen, FJH1
Bernsen, MR1
Martínez-Milla, J1
Galán-Arriola, C1
Carnero, M1
Cobiella, J1
Pérez-Camargo, D1
Bautista-Hernández, V1
Rigol, M1
Solanes, N1
Villena-Gutierrez, R1
Lobo, M1
Mateo, J1
Vilchez-Tschischke, JP1
Salinas, B1
Cussó, L1
López, GJ1
Fuster, V1
Desco, M1
Sanchez-González, J1
Ibanez, B1
van den Berg, P1
Schweitzer, DH1
van Haard, PMM1
Geusens, PP1
van den Bergh, JP1
Zhu, X1
Huang, X3
Xu, H2
Yang, G2
Lin, Z1
Salem, HF1
Nafady, MM1
Kharshoum, RM1
Abd El-Ghafar, OA1
Farouk, HO1
Domiciano, D1
Nery, FC1
de Carvalho, PA1
Prudente, DO1
de Souza, LB1
Chalfun-Júnior, A1
Paiva, R1
Marchiori, PER1
Lu, M2
An, Z1
Jiang, J2
Li, J7
Du, S1
Zhou, H1
Cui, J1
Wu, W1
Liu, Y9
Song, J1
Lian, Q1
Uddin Ahmad, Z1
Gang, DD1
Konggidinata, MI1
Gallo, AA1
Zappi, ME1
Yang, TWW1
Johari, Y1
Burton, PR1
Earnest, A1
Shaw, K1
Hare, JL1
Brown, WA1
Kim, GA1
Han, S1
Choi, GH1
Choi, J1
Lim, YS1
Gallo, A1
Cancelli, C1
Ceron, E1
Covino, M1
Capoluongo, E1
Pocino, K1
Ianiro, G1
Cammarota, G1
Gasbarrini, A1
Montalto, M1
Somasundar, Y1
Lu, IC1
Mills, MR1
Qian, LY1
Olivares, X1
Ryabov, AD1
Collins, TJ1
Zhao, L1
Doddipatla, S1
Thomas, AM1
Nikolayev, AA1
Galimova, GR1
Azyazov, VN1
Mebel, AM1
Kaiser, RI1
Guo, S1
Yang, P1
Yu, X2
Wu, Y2
Zhang, H1
Yu, B2
Han, B1
George, MW1
Moor, MB1
Bonny, O1
Langenberg, E1
Paik, H1
Smith, EH1
Nair, HP1
Hanke, I1
Ganschow, S1
Catalan, G1
Domingo, N1
Schlom, DG1
Assefa, MK1
Wu, G2
Hayton, TW1
Becker, B1
Enikeev, D1
Netsch, C1
Gross, AJ1
Laukhtina, E1
Glybochko, P1
Rapoport, L1
Herrmann, TRW1
Taratkin, M1
Dai, W1
Shi, J2
Carreno, J1
Kloner, RA1
Pickersgill, NA1
Vetter, JM1
Kim, EH1
Cope, SJ1
Du, K1
Venkatesh, R1
Giardina, JD1
Saad, NES1
Bhayani, SB1
Figenshau, RS1
Eriksson, J1
Landfeldt, E1
Ireland, S1
Jackson, C1
Wyatt, E1
Gaudig, M1
Stancill, JS1
Happ, JT1
Broniowska, KA1
Hogg, N1
Corbett, JA1
Tang, LF1
Bi, YL1
Fan, Y2
Sun, YB1
Wang, AL1
Xiao, BH1
Wang, LF1
Qiu, SW1
Guo, SW1
Wáng, YXJ1
Sun, J2
Chu, S1
Pan, Q1
Li, D4
Zheng, S2
Ma, L1
Wang, L3
Hu, T1
Wang, F1
Han, Z1
Yin, Z1
Ge, X1
Xie, K1
Lei, P1
Dias-Santagata, D1
Lennerz, JK1
Sadow, PM1
Frazier, RP1
Govinda Raju, S1
Henry, D1
Chung, T1
Kherani, J1
Rothenberg, SM1
Wirth, LJ1
Marti, CN1
Choi, NG1
Bae, SJ1
Ni, L1
Luo, X1
Dai, T1
Yang, Y3
Lee, R1
Fleischer, AS1
Wemhoff, AP1
Ford, CR1
Kleppinger, EL1
Helms, K1
Bush, AA1
Luna-Abanto, J1
García Ruiz, L1
Laura Martinez, J1
Álvarez Larraondo, M1
Villoslada Terrones, V1
Dukic, L1
Maric, N1
Simundic, AM1
Chogtu, B1
Ommurugan, B1
Thomson, SR1
Kalthur, SG1
Benidir, M1
El Massoudi, S1
El Ghadraoui, L1
Lazraq, A1
Benjelloun, M1
Errachidi, F1
Cassar, M1
Law, AD1
Chow, ES1
Giebultowicz, JM1
Kretzschmar, D1
Salonurmi, T1
Nabil, H1
Ronkainen, J1
Hyötyläinen, T1
Hautajärvi, H1
Savolainen, MJ1
Tolonen, A1
Orešič, M1
Känsäkoski, P1
Rysä, J1
Hakkola, J1
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Barb, J1
Collado, CJ1
Elloumi, F1
Palmieri, EM1
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Kolodgie, FD1
Finn, AV1
Biesecker, LG1
McVicar, DW1
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Tang, J3
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Zheng, G1
Xu, F1
Sun, W1
Yin, F1
van Hest, JCM1
Du, L2
Shi, X1
Kang, S1
Duan, W1
Zhang, S2
Feng, J2
Qi, N1
Shen, G1
Ren, H1
Shang, Q1
Zhao, W2
Yang, Z2
Jiang, X2
Alame, M1
Cornillot, E1
Cacheux, V1
Tosato, G1
Four, M1
De Oliveira, L1
Gofflot, S1
Delvenne, P1
Turtoi, E1
Cabello-Aguilar, S1
Nishiyama, M1
Turtoi, A1
Costes-Martineau, V1
Colinge, J1
Guo, Q1
Quan, M1
Dong, J1
Bai, J1
Han, R1
Cai, Y1
Lv, YQ1
Chen, Q1
Lyu, HD1
Deng, L1
Zhou, D1
Xiao, X1
De Langhe, S1
Billadeau, DD1
Lou, Z1
Zhang, JS1
Xue, Z1
Shen, XD1
Gao, F1
Busuttil, RW1
Kupiec-Weglinski, JW1
Ji, H1
Otano, I1
Alvarez, M1
Minute, L1
Ochoa, MC1
Migueliz, I1
Molina, C1
Azpilikueta, A1
de Andrea, CE1
Etxeberria, I1
Sanmamed, MF1
Teijeira, Á1
Berraondo, P1
Melero, I1
Zhong, Z1
Xie, X1
Yu, Q1
Zhou, C1
Liu, C2
Liu, W1
Chen, W1
Yin, Y1
Li, CW1
Hsu, JL1
Zhou, Q1
Hu, B1
Fu, P1
Atyah, M1
Ma, Q2
Xu, Y1
Dong, Q1
Hung, MC1
Ren, N1
Huang, P1
Liao, R1
Chen, X3
Cao, Q1
Yuan, X1
Nie, W1
Yang, J2
Shao, B1
Ma, X1
Bi, Z1
Liang, X1
Tie, Y1
Mo, F1
Xie, D1
Wei, Y1
Wei, X2
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Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II, Randomised, Double-blind, Placebo- Controlled, Multi-site, Parallel Group Clinical Trial to Examine Ketamine as a Pharmacological Treatment for Alcohol Dependence in an Alcohol Dependent Population[NCT02649231]Phase 296 participants (Actual)Interventional2016-10-31Completed
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression[NCT02417064]Phase 3346 participants (Actual)Interventional2015-08-10Completed
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression[NCT02418585]Phase 3236 participants (Actual)Interventional2015-08-07Completed
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression[NCT02493868]Phase 3719 participants (Actual)Interventional2015-10-01Completed
Evaluation of Schemes of Administration of Intravenous Ketamine in Treatment-resistant Depression: Clinical-neuroimaging Correlation[NCT03742557]Phase 330 participants (Anticipated)Interventional2018-10-01Recruiting
A Safe Ketamine-Based Therapy for Treatment Resistant Depression[NCT01179009]20 participants (Actual)Interventional2012-04-30Completed
A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy[NCT05019885]Phase 26 participants (Anticipated)Interventional2022-08-26Recruiting
Intravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic Cystitis[NCT04821882]29 participants (Actual)Interventional2019-05-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage Days Abstinent

Time line follow back (NCT02649231)
Timeframe: 6 months

Interventionpercentage of days abstinent (Mean)
Ketamine+Psychological Therapy86.4
Ketamine+Education82.5
Placebo+Psychological Therapy78.3
Placebo+Education70.7

Relapse Rates

Time line follow back (NCT02649231)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Ketamine+Psychological Therapy13
Ketamine+Education15
Placebo+Psychological Therapy14
Placebo+Education18

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score up to Endpoint (Double-blind Induction Phase [Day 28])

"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients (a decrease in score indicates improvement). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Median)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-2.0
Intranasal Esketamine 84 mg Plus Oral AD-2.0
Oral AD Plus Intranasal Placebo-1.0

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): EQ-VAS

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02417064)
Timeframe: Baseline up to end of Double-blind induction phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant20.9
Intranasal Esketamine 84 mg Plus Oral AD19.1
Oral AD Plus Intranasal Placebo14.9

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Health Status Index

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). (NCT02417064)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant0.224
Intranasal Esketamine 84 mg Plus Oral AD0.243
Oral AD Plus Intranasal Placebo0.181

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Sum Score

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state. (NCT02417064)
Timeframe: Baseline up to end of Double-blind Induction phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-19.0
Intranasal Esketamine 84 mg Plus Oral AD-19.4
Oral AD Plus Intranasal Placebo-14.6

Change From Baseline in Generalized Anxiety Disorder-7 Item (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants responded to each item using a 4 point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-7.4
Intranasal Esketamine 84 mg Plus Oral AD-7.7
Oral AD Plus Intranasal Placebo-6.0

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis

MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction Phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-19.0
Intranasal Esketamine 84 mg Plus Oral AD-18.8
Oral AD Plus Intranasal Placebo-14.8

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-18.3
Intranasal Esketamine 84 mg Plus Oral AD-17.4
Oral AD Plus Intranasal Placebo-14.3

Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-11.0
Intranasal Esketamine 84 mg Plus Oral AD-11.7
Oral AD Plus Intranasal Placebo-9.1

Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-10.9
Intranasal Esketamine 84 mg Plus Oral AD-10.9
Oral AD Plus Intranasal Placebo-8.9

Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired), where higher score indicates greater impairment. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-11.0
Intranasal Esketamine 84 mg Plus Oral AD-11.1
Oral AD Plus Intranasal Placebo-8.4

Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired) where higher score indicates greater impairment. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-10.7
Intranasal Esketamine 84 mg Plus Oral AD-10.2
Oral AD Plus Intranasal Placebo-8.1

Percentage of Participants in Remission (MADRS<=12) at Day 28 of Double-blind Induction Phase (Observed Data)

Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: At Day 28 of Double-blind Induction Phase

InterventionPercentage of participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant36
Intranasal Esketamine 84 mg Plus Oral AD38.8
Oral AD Plus Intranasal Placebo30.6

Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (LOCF Data)

"Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: At Day 28 (Double-blind Endpoint)

InterventionPercentage of participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant34.8
Intranasal Esketamine 84 mg Plus Oral AD35.4
Oral AD Plus Intranasal Placebo29.2

Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at Day 28 of Double-blind Induction Phase (Observed Data)

A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: At Day 28 of Double-blind Induction phase

InterventionPercentage of Participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant54.1
Intranasal Esketamine 84 mg Plus Oral AD53.1
Oral AD Plus Intranasal Placebo38.9

Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: At Day 28 (Double-blind Endpoint)

InterventionPercentage of Participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant53.0
Intranasal Esketamine 84 mg Plus Oral AD47.8
Oral AD Plus Intranasal Placebo37.2

Percentage of Participants With Onset of Clinical Response by Day 2 and Day 8

A participant was defined as having a clinical response if there was at least 50% improvement (decrease) from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, however score must show at least 25% improvement. Participants who did not meet these criteria or discontinued during the study before Day 28 were considered as non-responders and were assigned the value of 0 (that is no). MADRS is clinician-rated scale that consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), for total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: Day 2 up to Day 28 and Day 8 up to Day 28

,,
InterventionPercentage of Participants (Number)
Day 2 up to Day 28Day 8 up to Day 28
Intranasal Esketamine 56 mg Plus Oral Antidepressant10.413.0
Intranasal Esketamine 84 mg Plus Oral AD8.811.4
Oral AD Plus Intranasal Placebo1.83.5

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Median)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-2.0
Intranasal Placebo Plus Oral AD-2.0

Change From Baseline in EQ 5D-5L- European Quality of Life - Visual Analogue Scale (EQ-VAS) to End of Double-blind Induction Phase (Day 28)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)29.1
Intranasal Placebo Plus Oral AD20.9

Change From Baseline in EQ 5D-5L- Sum Score to End of Double-blind Induction Phase (Day 28)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-23.2
Intranasal Placebo Plus Oral AD-17.1

Change From Baseline in EQ 5D-5L-Health Status Index to End of Double-blind Induction Phase (Day 28)

"European Quality of Life Group-5 Dimension-5-Level (EQ-5D-5L) is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health)." (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)0.288
Intranasal Placebo Plus Oral AD0.231

Change From Baseline in Generalized Anxiety Disorder (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-7.9
Intranasal Placebo Plus Oral AD-6.8

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis

MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction Phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-21.4
Intranasal Placebo Plus Oral AD-17.0

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis

"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-19.6
Intranasal Placebo Plus Oral AD-16.3

Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day. Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-13.0
Intranasal Placebo Plus Oral AD-10.2

Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day). Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-12.2
Intranasal Placebo Plus Oral AD-10.1

Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-13.6
Intranasal Placebo Plus Oral AD-9.4

Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-12.5
Intranasal Placebo Plus Oral AD-9.3

Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])

"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: At Endpoint (Double-blind Induction Phase [Day 28])

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)48.2
Intranasal Placebo Plus Oral AD30.3

Percentage of Participants in Remission (SDS Total Score <=6 and Individual Item Scores Each <=2) at the End of 4-Week Double-blind Induction Phase (Day 28)

Remission defined as SDS total score <= 6 and individual item scores each <= 2. SDS is a participant reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: At Day 28 (End of Double-blind Induction Phase)

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)39.5
Intranasal Placebo Plus Oral AD20.9

Percentage of Participants in Response (SDS Total Score <=12 and Individual Item Scores Each <=4) at the End of 4-Week Double-blind Induction Phase (Day 28)

Response defined as SDS total score <= 12 and individual item scores each <= 4. SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: At Day 28 [end of Double-blind Induction Phase]

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)57.0
Intranasal Placebo Plus Oral AD39.5

Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28])

"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The percentage of participants with greater than or equal to (>=) 50 % reduction from baseline in MADRS total score was reported. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: At Endpoint (Double-blind Induction Phase [Day 28])

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)63.4
Intranasal Placebo Plus Oral AD49.5

Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8

A participant was defined as having a clinical response if there is at least 50 percent (%) improvement from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Participants who did not meet such criterion or discontinue during the study before Day 28 for any reason were considered as non-responders. (NCT02418585)
Timeframe: Day 2 up to Day 28 and Day 8 up to Day 28

,
InterventionPercentage of participants (Number)
Onset of Clinical response on Day 2Onset of Clinical response on Day 8
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)7.910.5
Intranasal Placebo Plus Oral AD4.66.4

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-10.4
Oral AD+ Intranasal Placebo-16.1

Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-1.3
Oral AD+ Intranasal Placebo-13.8

Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.067
Oral AD+ Intranasal Placebo-0.096

Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.023
Oral AD+ Intranasal Placebo-0.073

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo10.9

Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.0
Oral AD+ Intranasal Placebo8.4

Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo4.0

Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.4
Oral AD+ Intranasal Placebo2.6

Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward [LOCF] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo12.5

Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.4
Oral AD+ Intranasal Placebo11.4

Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.3
Oral AD+ Intranasal Placebo5.9

Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.7
Oral AD+ Intranasal Placebo4.7

Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.7
Oral AD+ Intranasal Placebo7.2

Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo6.8

Time to Relapse in Participants With Stable Remission (Maintenance Phase)

Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (>) 12 or one missing assessment at OP week 13 or 14. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)

InterventionDays (Median)
Intranasal Esketamine + Oral ADNA
Oral AD+ Intranasal Placebo273.0

Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

Relapse is defined as any of following: MADRS total score >= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as >= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)

InterventionDays (Median)
Intranasal Esketamine + Oral AD635.0
Oral AD+ Intranasal Placebo88.0

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures the severity of depression, with a higher score indicating a higher level of depression. The range of scores is 0 to 60. (NCT01179009)
Timeframe: 8 weeks

InterventionScores on a scale (Mean)
Ketamine 100-hour Infusion-9.0
Ketamine 40-minute Infusion-6.4

Reviews

5 reviews available for ketamine and Recrudescence

ArticleYear
    The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1

    Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P

2016
[Diagnosis and treatment of ketamine-associated cystitis: a report of 3 cases and literature review].
    Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences, 2013, Volume: 38, Issue:9

    Topics: Biopsy; Cystitis; Cystoscopy; Humans; Ketamine; Lower Urinary Tract Symptoms; Recurrence; Retrospect

2013
[Ketamine--a new treatment option for therapy-resistant depression].
    Fortschritte der Neurologie-Psychiatrie, 2015, Volume: 83, Issue:2

    Topics: Antidepressive Agents; Depressive Disorder, Treatment-Resistant; Drug Resistance; Excitatory Amino A

2015
Investigational drugs for treating major depressive disorder.
    Expert opinion on investigational drugs, 2017, Volume: 26, Issue:1

    Topics: Animals; Antidepressive Agents; Depressive Disorder, Major; Drug Design; Drugs, Investigational; Exc

2017
[Genetic study on schizophrenia and its recurrence utilizing pharmacological models].
    Seishin shinkeigaku zasshi = Psychiatria et neurologia Japonica, 2002, Volume: 104, Issue:6

    Topics: Amphetamine; Animals; Central Nervous System Stimulants; Cocaine; Disease Models, Animal; Dopamine A

2002

Trials

10 trials available for ketamine and Recrudescence

ArticleYear
Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder.
    The American journal of psychiatry, 2022, Volume: 179, Issue:2

    Topics: Adult; Alcohol Drinking; Alcoholism; Double-Blind Method; Female; Humans; Ketamine; Male; Recurrence

2022
Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression.
    The New England journal of medicine, 2023, Oct-05, Volume: 389, Issue:14

    Topics: Antidepressive Agents; Delayed-Action Preparations; Depression; Depressive Disorder, Treatment-Resis

2023
Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2]).
    BMC psychiatry, 2023, Nov-16, Volume: 23, Issue:1

    Topics: Adult; Antidepressive Agents; Depression; Depressive Disorder, Major; Humans; Ketamine; Midazolam; Q

2023
    The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1

    Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P

2016
A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial.
    Trials, 2017, 04-04, Volume: 18, Issue:1

    Topics: Adolescent; Adult; Alcohol Abstinence; Alcohol Drinking; Alcoholism; Combined Modality Therapy; Doub

2017
Cognitive Behavior Therapy May Sustain Antidepressant Effects of Intravenous Ketamine in Treatment-Resistant Depression.
    Psychotherapy and psychosomatics, 2017, Volume: 86, Issue:3

    Topics: Administration, Intravenous; Adult; Antidepressive Agents; Cognition; Cognitive Behavioral Therapy;

2017
Time until relapse after augmentation with single-dose ketamine in treatment-resistant depression.
    Psychiatry and clinical neurosciences, 2018, Volume: 72, Issue:8

    Topics: Adult; Antidepressive Agents; Depressive Disorder, Treatment-Resistant; Drug Synergism; Excitatory A

2018
Ketamine Versus Midazolam for Depression Relapse Prevention Following Successful Electroconvulsive Therapy: A Randomized Controlled Pilot Trial.
    The journal of ECT, 2019, Volume: 35, Issue:2

    Topics: Aged; Aged, 80 and over; Anesthetics, Dissociative; Anesthetics, Intravenous; Depressive Disorder, M

2019
Pilot dose-response trial of i.v. ketamine in treatment-resistant depression.
    The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry, 2014, Volume: 15, Issue:7

    Topics: Adult; Aged; Cross-Over Studies; Depressive Disorder, Treatment-Resistant; Dose-Response Relationshi

2014
Dextromethorphan challenge in alcohol-dependent patients and controls.
    Archives of general psychiatry, 2000, Volume: 57, Issue:3

    Topics: Alcohol Drinking; Alcoholism; Behavior, Addictive; Dextromethorphan; Dextrorphan; Double-Blind Metho

2000

Other Studies

21 other studies available for ketamine and Recrudescence

ArticleYear
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
    The international journal of neuropsychopharmacology, 2022, 04-19, Volume: 25, Issue:4

    Topics: Antidepressive Agents; Clinical Trials, Phase III as Topic; Depression; Depressive Disorder, Treatme

2022
Time to relapse after a single administration of intravenous ketamine augmentation in unipolar treatment-resistant depression.
    Journal of affective disorders, 2020, 01-01, Volume: 260

    Topics: Adult; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Female; Humans; Infusio

2020
Effectiveness of a brief information, motivation and behavioral skills program on stage transitions and lapse for individuals who use ketamine.
    Drug and alcohol dependence, 2019, 11-01, Volume: 204

    Topics: Adult; Behavior Therapy; Female; Health Knowledge, Attitudes, Practice; Humans; Ketamine; Male; Midd

2019
Ineffectiveness of Repeated Intravenous Ketamine Infusions in Treatment-Resistant Depression After a Post-Ketamine Relapse: Time for a Rethink?
    Journal of clinical psychopharmacology, 2018, Volume: 38, Issue:5

    Topics: Antidepressive Agents; Depressive Disorder, Treatment-Resistant; Female; Humans; Infusions, Intraven

2018
Difference in long-term relapse rates between youths with ketamine use and those with stimulants use.
    Substance abuse treatment, prevention, and policy, 2018, 12-22, Volume: 13, Issue:1

    Topics: Adolescent; Central Nervous System Stimulants; Child; Excitatory Amino Acid Antagonists; Female; Hum

2018
The effects of GSK-3β blockade on ketamine self-administration and relapse to drug-seeking behavior in rats.
    Drug and alcohol dependence, 2015, Feb-01, Volume: 147

    Topics: Animals; Drug-Seeking Behavior; Glycogen Synthase Kinase 3; Glycogen Synthase Kinase 3 beta; Indoles

2015
Ketamine in refractory convulsive status epilepticus in children avoids endotracheal intubation.
    Epilepsy & behavior : E&B, 2015, Volume: 49

    Topics: Administration, Intravenous; Anesthetics, Dissociative; Cerebral Cortex; Child; Child, Preschool; Cl

2015
Rates and Correlates of Syphilis Reinfection in Men Who Have Sex with Men.
    LGBT health, 2017, Volume: 4, Issue:3

    Topics: Adult; Anesthetics, Dissociative; Coinfection; Follow-Up Studies; HIV Infections; Homosexuality, Mal

2017
Differential characteristics of ketamine self-administration in the olfactory bulbectomy model of depression in male rats.
    Experimental and clinical psychopharmacology, 2017, Volume: 25, Issue:2

    Topics: Animals; Antidepressive Agents; Behavior, Animal; Conditioning, Operant; Depression; Disease Models,

2017
Cannabinoid CB(1) receptor antagonist rimonabant attenuates reinstatement of ketamine conditioned place preference in rats.
    European journal of pharmacology, 2008, Jul-28, Volume: 589, Issue:1-3

    Topics: Animals; Behavior, Animal; Conditioning, Psychological; Disease Models, Animal; Dose-Response Relati

2008
Ketamine successfully terminates malignant status epilepticus.
    Epilepsy research, 2008, Volume: 82, Issue:2-3

    Topics: Anesthesia, General; Anesthetics, Dissociative; Anticonvulsants; Coma; DNA Polymerase gamma; DNA-Dir

2008
Ketamine-induced biliary dilatation: from Hong Kong to New York.
    Journal of addiction medicine, 2012, Volume: 6, Issue:1

    Topics: Abdominal Pain; Adolescent; Adult; Anesthetics, Dissociative; Asian; Bile Duct Diseases; Cholangiopa

2012
Recurrent episodes of intractable laryngospasm during dissociative sedation with intramuscular ketamine.
    Pediatric emergency care, 2006, Volume: 22, Issue:4

    Topics: Anesthetics, Dissociative; Child, Preschool; Facial Injuries; Female; Humans; Injections, Intramuscu

2006
Rapid relief of severe major depressive disorder by use of preoperative ketamine and electroconvulsive therapy.
    The journal of ECT, 2007, Volume: 23, Issue:1

    Topics: Combined Modality Therapy; Depressive Disorder, Major; Electroconvulsive Therapy; Excitatory Amino A

2007
Ketamine-associated ulcerative cystitis: a new clinical entity.
    Urology, 2007, Volume: 69, Issue:5

    Topics: Adult; Biopsy, Needle; Cystitis; Cystoscopy; Female; Follow-Up Studies; Humans; Ketamine; Male; Pent

2007
Repeated intravenous ketamine therapy in a patient with treatment-resistant major depression.
    The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry, 2009, Volume: 10, Issue:4 Pt 2

    Topics: Anesthetics, Dissociative; Antidepressive Agents; Depressive Disorder, Major; Drug Administration Sc

2009
Ketamine induction for cesarean section in a patient with acute intermittent porphyria and achondroplastic dwarfism.
    Anesthesiology, 1983, Volume: 59, Issue:2

    Topics: Achondroplasia; Acute Disease; Adult; Anesthesia, General; Anesthesia, Obstetrical; Cesarean Section

1983
A new protocol for the treatment of hand deformities in recessive dystrophic epidermolysis bullosa (13 cases).
    Annales de chirurgie de la main et du membre superieur : organe officiel des societes de chirurgie de la main = Annals of hand and upper limb surgery, 1997, Volume: 16, Issue:2

    Topics: Activities of Daily Living; Anesthesia, Intravenous; Anesthetics, Dissociative; Brachial Plexus; Chi

1997
Conscious sedation: a new approach for peritonsillar abscess drainage in the pediatric population.
    Archives of otolaryngology--head & neck surgery, 1999, Volume: 125, Issue:11

    Topics: Adolescent; Anesthetics, Dissociative; Cellulitis; Chi-Square Distribution; Child; Child, Preschool;

1999
Effects of posterior parietal lesions on visually guided behavior in monkeys.
    Neuropsychologia, 1978, Volume: 16, Issue:2

    Topics: Animals; Female; Functional Laterality; Hand; Haplorhini; Ketamine; Macaca; Movement; Parietal Lobe;

1978
[Analysis of the surgical treatment of inguinal hernias].
    Vestnik khirurgii imeni I. I. Grekova, 1986, Volume: 137, Issue:12

    Topics: Anesthesia, General; Anesthesia, Local; Female; Hernia, Inguinal; Humans; Ketamine; Length of Stay;

1986