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.
Excerpt | Relevance | Reference |
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"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." | 9.69 | Esketamine 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." | 9.69 | Study 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." | 8.12 | Relationship 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." | 7.81 | Ketamine 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." | 7.74 | Ketamine-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." | 5.69 | Esketamine 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." | 5.69 | Study 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." | 5.46 | Differential 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." | 4.12 | Relationship 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." | 3.81 | Ketamine 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." | 3.74 | Ketamine-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." | 2.90 | Ketamine 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." | 2.84 | A 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." | 2.84 | Cognitive 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." | 2.79 | Pilot 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." | 1.56 | Time 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." | 1.46 | Differential 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." | 1.38 | Ketamine-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." | 1.34 | Rapid 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." | 1.30 | A 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." | 1.30 | Conscious sedation: a new approach for peritonsillar abscess drainage in the pediatric population. ( Lusk, RP; Muntz, HR; Park, J; Piccirillo, JF; Suskind, DL, 1999) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 3 (8.57) | 18.7374 |
1990's | 2 (5.71) | 18.2507 |
2000's | 8 (22.86) | 29.6817 |
2010's | 17 (48.57) | 24.3611 |
2020's | 5 (14.29) | 2.80 |
Authors | Studies |
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Grabski, M | 1 |
McAndrew, A | 2 |
Lawn, W | 2 |
Marsh, B | 1 |
Raymen, L | 1 |
Stevens, T | 2 |
Hardy, L | 1 |
Warren, F | 1 |
Bloomfield, M | 1 |
Borissova, A | 1 |
Maschauer, E | 1 |
Broomby, R | 1 |
Price, R | 1 |
Coathup, R | 1 |
Gilhooly, D | 1 |
Palmer, E | 1 |
Gordon-Williams, R | 1 |
Hill, R | 1 |
Harris, J | 1 |
Mollaahmetoglu, OM | 1 |
Curran, HV | 1 |
Brandner, B | 2 |
Lingford-Hughes, A | 1 |
Morgan, CJA | 1 |
Chen, G | 1 |
Chen, L | 3 |
Zhang, Y | 7 |
Li, X | 6 |
Lane, R | 1 |
Lim, P | 1 |
Daly, EJ | 1 |
Furey, ML | 1 |
Fedgchin, M | 1 |
Popova, V | 1 |
Singh, JB | 1 |
Drevets, WC | 1 |
Reif, A | 1 |
Bitter, I | 1 |
Buyze, J | 1 |
Cebulla, K | 1 |
Frey, R | 1 |
Fu, DJ | 1 |
Ito, T | 1 |
Kambarov, Y | 1 |
Llorca, PM | 1 |
Oliveira-Maia, AJ | 1 |
Messer, T | 1 |
Mulhern-Haughey, S | 1 |
Rive, B | 1 |
von Holt, C | 1 |
Young, AH | 1 |
Godinov, Y | 1 |
Jelovac, A | 1 |
McCaffrey, C | 1 |
Terao, M | 1 |
Shanahan, E | 2 |
Mohamed, E | 1 |
Whooley, E | 1 |
McDonagh, K | 1 |
McDonogh, S | 1 |
Igoe, A | 1 |
Loughran, O | 1 |
Shackleton, E | 1 |
O'Neill, C | 1 |
McLoughlin, DM | 2 |
Salloum, NC | 1 |
Fava, M | 1 |
Hock, RS | 1 |
Freeman, MP | 1 |
Flynn, M | 1 |
Hoeppner, B | 1 |
Cusin, C | 1 |
Iosifescu, DV | 1 |
Trivedi, MH | 1 |
Sanacora, G | 2 |
Mathew, SJ | 1 |
Debattista, C | 1 |
Ionescu, DF | 1 |
Papakostas, GI | 1 |
Hung, CC | 1 |
Su, LW | 1 |
Yen, MY | 1 |
Chuang, P | 1 |
Yang, HJ | 1 |
Lee, TS | 1 |
Halim, AA | 1 |
Alsayed, B | 1 |
Embarak, S | 1 |
Yaseen, T | 1 |
Dabbous, S | 1 |
Fontaine, O | 1 |
Dueluzeau, R | 1 |
Raibaud, P | 1 |
Chabanet, C | 1 |
Popoff, MR | 1 |
Badoual, J | 1 |
Gabilan, JC | 1 |
Andremont, A | 1 |
Gómez, L | 1 |
Andrés, S | 1 |
Sánchez, J | 1 |
Alonso, JM | 1 |
Rey, J | 1 |
López, F | 1 |
Jiménez, A | 1 |
Yan, Z | 1 |
Zhou, L | 1 |
Zhao, Y | 3 |
Wang, J | 7 |
Huang, L | 3 |
Hu, K | 1 |
Liu, H | 4 |
Wang, H | 3 |
Guo, Z | 1 |
Song, Y | 1 |
Huang, H | 4 |
Yang, R | 1 |
Owen, TW | 1 |
Al-Kaysi, RO | 1 |
Bardeen, CJ | 1 |
Cheng, Q | 1 |
Wu, S | 1 |
Cheng, T | 1 |
Zhou, X | 1 |
Wang, B | 4 |
Zhang, Q | 4 |
Wu, X | 2 |
Yao, Y | 3 |
Ochiai, T | 1 |
Ishiguro, H | 2 |
Nakano, R | 2 |
Kubota, Y | 2 |
Hara, M | 1 |
Sunada, K | 1 |
Hashimoto, K | 1 |
Kajioka, J | 1 |
Fujishima, A | 1 |
Jiao, J | 3 |
Gai, QY | 3 |
Wang, W | 2 |
Zang, YP | 2 |
Niu, LL | 2 |
Fu, YJ | 3 |
Wang, X | 4 |
Yao, LP | 1 |
Qin, QP | 1 |
Wang, ZY | 1 |
Liu, J | 4 |
Aleksic Sabo, V | 1 |
Knezevic, P | 1 |
Borges-Argáez, R | 1 |
Chan-Balan, R | 1 |
Cetina-Montejo, L | 1 |
Ayora-Talavera, G | 1 |
Sansores-Peraza, P | 1 |
Gómez-Carballo, J | 1 |
Cáceres-Farfán, M | 1 |
Jang, J | 1 |
Akin, D | 1 |
Bashir, R | 1 |
Yu, Z | 1 |
Zhu, J | 2 |
Jiang, H | 1 |
He, C | 2 |
Xiao, Z | 1 |
Xu, J | 2 |
Sun, Q | 1 |
Han, D | 1 |
Lei, H | 1 |
Zhao, K | 2 |
Zhu, L | 1 |
Fu, H | 2 |
Wilson, BK | 1 |
Step, DL | 1 |
Maxwell, CL | 1 |
Gifford, CA | 1 |
Richards, CJ | 1 |
Krehbiel, CR | 1 |
Warner, JM | 1 |
Doerr, AJ | 1 |
Erickson, GE | 1 |
Guretzky, JA | 1 |
Rasby, RJ | 1 |
Watson, AK | 1 |
Klopfenstein, TJ | 1 |
Sun, Y | 4 |
Liu, Z | 3 |
Pham, TD | 1 |
Lee, BK | 1 |
Yang, FC | 1 |
Wu, KH | 1 |
Lin, WP | 1 |
Hu, MK | 1 |
Lin, L | 3 |
Shao, J | 1 |
Sun, M | 1 |
Xu, G | 1 |
Zhang, X | 6 |
Xu, N | 1 |
Wang, R | 1 |
Liu, S | 1 |
He, H | 1 |
Dong, X | 2 |
Yang, M | 2 |
Yang, Q | 1 |
Duan, S | 1 |
Yu, Y | 2 |
Han, J | 2 |
Zhang, C | 3 |
Yang, X | 1 |
Li, W | 3 |
Wang, T | 2 |
Campbell, DA | 1 |
Gao, K | 1 |
Zager, RA | 1 |
Johnson, ACM | 1 |
Guillem, A | 1 |
Keyser, J | 1 |
Singh, B | 1 |
Steubl, D | 1 |
Schneider, MP | 1 |
Meiselbach, H | 1 |
Nadal, J | 1 |
Schmid, MC | 1 |
Saritas, T | 1 |
Krane, V | 1 |
Sommerer, C | 1 |
Baid-Agrawal, S | 1 |
Voelkl, J | 1 |
Kotsis, F | 1 |
Köttgen, A | 1 |
Eckardt, KU | 1 |
Scherberich, JE | 1 |
Li, H | 4 |
Yao, L | 2 |
Sun, L | 3 |
Zhu, Z | 1 |
Naren, N | 1 |
Zhang, XX | 2 |
Gentile, GL | 1 |
Rupert, AS | 1 |
Carrasco, LI | 1 |
Garcia, EM | 1 |
Kumar, NG | 1 |
Walsh, SW | 1 |
Jefferson, KK | 1 |
Guest, RL | 1 |
Samé Guerra, D | 1 |
Wissler, M | 1 |
Grimm, J | 1 |
Silhavy, TJ | 1 |
Lee, JH | 2 |
Yoo, JS | 1 |
Kim, Y | 1 |
Kim, JS | 2 |
Lee, EJ | 1 |
Roe, JH | 1 |
Delorme, M | 1 |
Bouchard, PA | 1 |
Simon, M | 1 |
Simard, S | 1 |
Lellouche, F | 1 |
D'Urzo, KA | 1 |
Mok, F | 1 |
D'Urzo, AD | 1 |
Koneru, B | 1 |
Lopez, G | 1 |
Farooqi, A | 1 |
Conkrite, KL | 1 |
Nguyen, TH | 1 |
Macha, SJ | 1 |
Modi, A | 1 |
Rokita, JL | 1 |
Urias, E | 1 |
Hindle, A | 1 |
Davidson, H | 1 |
Mccoy, K | 1 |
Nance, J | 1 |
Yazdani, V | 1 |
Irwin, MS | 1 |
Yang, S | 2 |
Wheeler, DA | 1 |
Maris, JM | 1 |
Diskin, SJ | 1 |
Reynolds, CP | 1 |
Abhilash, L | 1 |
Kalliyil, A | 1 |
Sheeba, V | 1 |
Hartley, AM | 2 |
Meunier, B | 2 |
Pinotsis, N | 1 |
Maréchal, A | 2 |
Xu, JY | 1 |
Genko, N | 1 |
Haraux, F | 1 |
Rich, PR | 1 |
Kamalanathan, M | 1 |
Doyle, SM | 1 |
Xu, C | 1 |
Achberger, AM | 1 |
Wade, TL | 1 |
Schwehr, K | 1 |
Santschi, PH | 1 |
Sylvan, JB | 1 |
Quigg, A | 1 |
Leong, W | 1 |
Xu, W | 2 |
Gao, S | 1 |
Zhai, X | 1 |
Wang, C | 2 |
Gilson, E | 1 |
Ye, J | 1 |
Lu, Y | 1 |
Yan, R | 1 |
Hu, Z | 1 |
You, Q | 1 |
Cai, Q | 1 |
Yang, D | 1 |
Gu, S | 1 |
Dai, H | 1 |
Zhao, X | 1 |
Gui, C | 1 |
Gui, J | 1 |
Wu, PK | 1 |
Hong, SK | 1 |
Starenki, D | 1 |
Oshima, K | 1 |
Shao, H | 1 |
Gestwicki, JE | 1 |
Tsai, S | 1 |
Park, JI | 1 |
Wang, Y | 7 |
Zhao, R | 1 |
Gu, Z | 1 |
Dong, C | 2 |
Guo, G | 1 |
Li, L | 4 |
Barrett, HE | 1 |
Meester, EJ | 1 |
van Gaalen, K | 1 |
van der Heiden, K | 1 |
Krenning, BJ | 1 |
Beekman, FJ | 1 |
de Blois, E | 1 |
de Swart, J | 1 |
Verhagen, HJ | 1 |
Maina, T | 1 |
Nock, BA | 1 |
Norenberg, JP | 1 |
de Jong, M | 1 |
Gijsen, FJH | 1 |
Bernsen, MR | 1 |
Martínez-Milla, J | 1 |
Galán-Arriola, C | 1 |
Carnero, M | 1 |
Cobiella, J | 1 |
Pérez-Camargo, D | 1 |
Bautista-Hernández, V | 1 |
Rigol, M | 1 |
Solanes, N | 1 |
Villena-Gutierrez, R | 1 |
Lobo, M | 1 |
Mateo, J | 1 |
Vilchez-Tschischke, JP | 1 |
Salinas, B | 1 |
Cussó, L | 1 |
López, GJ | 1 |
Fuster, V | 1 |
Desco, M | 1 |
Sanchez-González, J | 1 |
Ibanez, B | 1 |
van den Berg, P | 1 |
Schweitzer, DH | 1 |
van Haard, PMM | 1 |
Geusens, PP | 1 |
van den Bergh, JP | 1 |
Zhu, X | 1 |
Huang, X | 3 |
Xu, H | 2 |
Yang, G | 2 |
Lin, Z | 1 |
Salem, HF | 1 |
Nafady, MM | 1 |
Kharshoum, RM | 1 |
Abd El-Ghafar, OA | 1 |
Farouk, HO | 1 |
Domiciano, D | 1 |
Nery, FC | 1 |
de Carvalho, PA | 1 |
Prudente, DO | 1 |
de Souza, LB | 1 |
Chalfun-Júnior, A | 1 |
Paiva, R | 1 |
Marchiori, PER | 1 |
Lu, M | 2 |
An, Z | 1 |
Jiang, J | 2 |
Li, J | 7 |
Du, S | 1 |
Zhou, H | 1 |
Cui, J | 1 |
Wu, W | 1 |
Liu, Y | 9 |
Song, J | 1 |
Lian, Q | 1 |
Uddin Ahmad, Z | 1 |
Gang, DD | 1 |
Konggidinata, MI | 1 |
Gallo, AA | 1 |
Zappi, ME | 1 |
Yang, TWW | 1 |
Johari, Y | 1 |
Burton, PR | 1 |
Earnest, A | 1 |
Shaw, K | 1 |
Hare, JL | 1 |
Brown, WA | 1 |
Kim, GA | 1 |
Han, S | 1 |
Choi, GH | 1 |
Choi, J | 1 |
Lim, YS | 1 |
Gallo, A | 1 |
Cancelli, C | 1 |
Ceron, E | 1 |
Covino, M | 1 |
Capoluongo, E | 1 |
Pocino, K | 1 |
Ianiro, G | 1 |
Cammarota, G | 1 |
Gasbarrini, A | 1 |
Montalto, M | 1 |
Somasundar, Y | 1 |
Lu, IC | 1 |
Mills, MR | 1 |
Qian, LY | 1 |
Olivares, X | 1 |
Ryabov, AD | 1 |
Collins, TJ | 1 |
Zhao, L | 1 |
Doddipatla, S | 1 |
Thomas, AM | 1 |
Nikolayev, AA | 1 |
Galimova, GR | 1 |
Azyazov, VN | 1 |
Mebel, AM | 1 |
Kaiser, RI | 1 |
Guo, S | 1 |
Yang, P | 1 |
Yu, X | 2 |
Wu, Y | 2 |
Zhang, H | 1 |
Yu, B | 2 |
Han, B | 1 |
George, MW | 1 |
Moor, MB | 1 |
Bonny, O | 1 |
Langenberg, E | 1 |
Paik, H | 1 |
Smith, EH | 1 |
Nair, HP | 1 |
Hanke, I | 1 |
Ganschow, S | 1 |
Catalan, G | 1 |
Domingo, N | 1 |
Schlom, DG | 1 |
Assefa, MK | 1 |
Wu, G | 2 |
Hayton, TW | 1 |
Becker, B | 1 |
Enikeev, D | 1 |
Netsch, C | 1 |
Gross, AJ | 1 |
Laukhtina, E | 1 |
Glybochko, P | 1 |
Rapoport, L | 1 |
Herrmann, TRW | 1 |
Taratkin, M | 1 |
Dai, W | 1 |
Shi, J | 2 |
Carreno, J | 1 |
Kloner, RA | 1 |
Pickersgill, NA | 1 |
Vetter, JM | 1 |
Kim, EH | 1 |
Cope, SJ | 1 |
Du, K | 1 |
Venkatesh, R | 1 |
Giardina, JD | 1 |
Saad, NES | 1 |
Bhayani, SB | 1 |
Figenshau, RS | 1 |
Eriksson, J | 1 |
Landfeldt, E | 1 |
Ireland, S | 1 |
Jackson, C | 1 |
Wyatt, E | 1 |
Gaudig, M | 1 |
Stancill, JS | 1 |
Happ, JT | 1 |
Broniowska, KA | 1 |
Hogg, N | 1 |
Corbett, JA | 1 |
Tang, LF | 1 |
Bi, YL | 1 |
Fan, Y | 2 |
Sun, YB | 1 |
Wang, AL | 1 |
Xiao, BH | 1 |
Wang, LF | 1 |
Qiu, SW | 1 |
Guo, SW | 1 |
Wáng, YXJ | 1 |
Sun, J | 2 |
Chu, S | 1 |
Pan, Q | 1 |
Li, D | 4 |
Zheng, S | 2 |
Ma, L | 1 |
Wang, L | 3 |
Hu, T | 1 |
Wang, F | 1 |
Han, Z | 1 |
Yin, Z | 1 |
Ge, X | 1 |
Xie, K | 1 |
Lei, P | 1 |
Dias-Santagata, D | 1 |
Lennerz, JK | 1 |
Sadow, PM | 1 |
Frazier, RP | 1 |
Govinda Raju, S | 1 |
Henry, D | 1 |
Chung, T | 1 |
Kherani, J | 1 |
Rothenberg, SM | 1 |
Wirth, LJ | 1 |
Marti, CN | 1 |
Choi, NG | 1 |
Bae, SJ | 1 |
Ni, L | 1 |
Luo, X | 1 |
Dai, T | 1 |
Yang, Y | 3 |
Lee, R | 1 |
Fleischer, AS | 1 |
Wemhoff, AP | 1 |
Ford, CR | 1 |
Kleppinger, EL | 1 |
Helms, K | 1 |
Bush, AA | 1 |
Luna-Abanto, J | 1 |
García Ruiz, L | 1 |
Laura Martinez, J | 1 |
Álvarez Larraondo, M | 1 |
Villoslada Terrones, V | 1 |
Dukic, L | 1 |
Maric, N | 1 |
Simundic, AM | 1 |
Chogtu, B | 1 |
Ommurugan, B | 1 |
Thomson, SR | 1 |
Kalthur, SG | 1 |
Benidir, M | 1 |
El Massoudi, S | 1 |
El Ghadraoui, L | 1 |
Lazraq, A | 1 |
Benjelloun, M | 1 |
Errachidi, F | 1 |
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Zaller, N | 1 |
Gao, P | 1 |
Sun, YH | 1 |
Zhang, HB | 1 |
Porffy, L | 1 |
Morgan, CJ | 1 |
Wilkinson, ST | 1 |
Wright, D | 1 |
Fasula, MK | 1 |
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Griepp, M | 1 |
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Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 2 | 96 participants (Actual) | Interventional | 2016-10-31 | Completed | ||
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 3 | 346 participants (Actual) | Interventional | 2015-08-10 | Completed | ||
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 3 | 236 participants (Actual) | Interventional | 2015-08-07 | Completed | ||
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression[NCT02493868] | Phase 3 | 719 participants (Actual) | Interventional | 2015-10-01 | Completed | ||
Evaluation of Schemes of Administration of Intravenous Ketamine in Treatment-resistant Depression: Clinical-neuroimaging Correlation[NCT03742557] | Phase 3 | 30 participants (Anticipated) | Interventional | 2018-10-01 | Recruiting | ||
A Safe Ketamine-Based Therapy for Treatment Resistant Depression[NCT01179009] | 20 participants (Actual) | Interventional | 2012-04-30 | Completed | |||
A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy[NCT05019885] | Phase 2 | 6 participants (Anticipated) | Interventional | 2022-08-26 | Recruiting | ||
Intravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic Cystitis[NCT04821882] | 29 participants (Actual) | Interventional | 2019-05-01 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Time line follow back (NCT02649231)
Timeframe: 6 months
Intervention | percentage of days abstinent (Mean) |
---|---|
Ketamine+Psychological Therapy | 86.4 |
Ketamine+Education | 82.5 |
Placebo+Psychological Therapy | 78.3 |
Placebo+Education | 70.7 |
Time line follow back (NCT02649231)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|---|
Ketamine+Psychological Therapy | 13 |
Ketamine+Education | 15 |
Placebo+Psychological Therapy | 14 |
Placebo+Education | 18 |
"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)
Intervention | Units 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 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 20.9 |
Intranasal Esketamine 84 mg Plus Oral AD | 19.1 |
Oral AD Plus Intranasal Placebo | 14.9 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 0.224 |
Intranasal Esketamine 84 mg Plus Oral AD | 0.243 |
Oral AD Plus Intranasal Placebo | 0.181 |
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)
Intervention | Units 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 |
"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)
Intervention | Units 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 |
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
Intervention | Units 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 |
"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)
Intervention | Units 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 |
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
Intervention | Units 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 |
"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)
Intervention | Units 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 |
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
Intervention | Units 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 |
"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)
Intervention | Units 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 |
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
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 36 |
Intranasal Esketamine 84 mg Plus Oral AD | 38.8 |
Oral AD Plus Intranasal Placebo | 30.6 |
"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)
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 34.8 |
Intranasal Esketamine 84 mg Plus Oral AD | 35.4 |
Oral AD Plus Intranasal Placebo | 29.2 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 54.1 |
Intranasal Esketamine 84 mg Plus Oral AD | 53.1 |
Oral AD Plus Intranasal Placebo | 38.9 |
"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)
Intervention | Percentage of Participants (Number) |
---|---|
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 53.0 |
Intranasal Esketamine 84 mg Plus Oral AD | 47.8 |
Oral AD Plus Intranasal Placebo | 37.2 |
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
Intervention | Percentage of Participants (Number) | |
---|---|---|
Day 2 up to Day 28 | Day 8 up to Day 28 | |
Intranasal Esketamine 56 mg Plus Oral Antidepressant | 10.4 | 13.0 |
Intranasal Esketamine 84 mg Plus Oral AD | 8.8 | 11.4 |
Oral AD Plus Intranasal Placebo | 1.8 | 3.5 |
"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])
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -2.0 |
Intranasal Placebo Plus Oral AD | -2.0 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 29.1 |
Intranasal Placebo Plus Oral AD | 20.9 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -23.2 |
Intranasal Placebo Plus Oral AD | -17.1 |
"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)
Intervention | Units on a Scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 0.288 |
Intranasal Placebo Plus Oral AD | 0.231 |
"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])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -7.9 |
Intranasal Placebo Plus Oral AD | -6.8 |
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
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -21.4 |
Intranasal Placebo Plus Oral AD | -17.0 |
"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])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -19.6 |
Intranasal Placebo Plus Oral AD | -16.3 |
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
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -13.0 |
Intranasal Placebo Plus Oral AD | -10.2 |
"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])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -12.2 |
Intranasal Placebo Plus Oral AD | -10.1 |
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
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -13.6 |
Intranasal Placebo Plus Oral AD | -9.4 |
"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])
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | -12.5 |
Intranasal Placebo Plus Oral AD | -9.3 |
"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])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 48.2 |
Intranasal Placebo Plus Oral AD | 30.3 |
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)
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 39.5 |
Intranasal Placebo Plus Oral AD | 20.9 |
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]
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 57.0 |
Intranasal Placebo Plus Oral AD | 39.5 |
"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])
Intervention | Percentage of participants (Number) |
---|---|
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 63.4 |
Intranasal Placebo Plus Oral AD | 49.5 |
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
Intervention | Percentage of participants (Number) | |
---|---|---|
Onset of Clinical response on Day 2 | Onset of Clinical response on Day 8 | |
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD) | 7.9 | 10.5 |
Intranasal Placebo Plus Oral AD | 4.6 | 6.4 |
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)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine + Oral AD | 0.0 |
Oral AD+ Intranasal Placebo | 1.0 |
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)
Intervention | Units on a scale (Median) |
---|---|
Intranasal Esketamine + Oral AD | 0.0 |
Oral AD+ Intranasal Placebo | 1.0 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -10.4 |
Oral AD+ Intranasal Placebo | -16.1 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -1.3 |
Oral AD+ Intranasal Placebo | -13.8 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -0.067 |
Oral AD+ Intranasal Placebo | -0.096 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | -0.023 |
Oral AD+ Intranasal Placebo | -0.073 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 7.5 |
Oral AD+ Intranasal Placebo | 10.9 |
"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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 3.0 |
Oral AD+ Intranasal Placebo | 8.4 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 2.2 |
Oral AD+ Intranasal Placebo | 4.0 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 1.4 |
Oral AD+ Intranasal Placebo | 2.6 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 7.5 |
Oral AD+ Intranasal Placebo | 12.5 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 4.4 |
Oral AD+ Intranasal Placebo | 11.4 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 3.3 |
Oral AD+ Intranasal Placebo | 5.9 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 1.7 |
Oral AD+ Intranasal Placebo | 4.7 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 4.7 |
Oral AD+ Intranasal Placebo | 7.2 |
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)
Intervention | Units on a scale (Mean) |
---|---|
Intranasal Esketamine + Oral AD | 2.2 |
Oral AD+ Intranasal Placebo | 6.8 |
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)
Intervention | Days (Median) |
---|---|
Intranasal Esketamine + Oral AD | NA |
Oral AD+ Intranasal Placebo | 273.0 |
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)
Intervention | Days (Median) |
---|---|
Intranasal Esketamine + Oral AD | 635.0 |
Oral AD+ Intranasal Placebo | 88.0 |
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
Intervention | Scores on a scale (Mean) |
---|---|
Ketamine 100-hour Infusion | -9.0 |
Ketamine 40-minute Infusion | -6.4 |
5 reviews available for ketamine and Recrudescence
Article | Year |
---|---|
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].
Topics: Biopsy; Cystitis; Cystoscopy; Humans; Ketamine; Lower Urinary Tract Symptoms; Recurrence; Retrospect | 2013 |
[Ketamine--a new treatment option for therapy-resistant depression].
Topics: Antidepressive Agents; Depressive Disorder, Treatment-Resistant; Drug Resistance; Excitatory Amino A | 2015 |
Investigational drugs for treating major depressive disorder.
Topics: Animals; Antidepressive Agents; Depressive Disorder, Major; Drug Design; Drugs, Investigational; Exc | 2017 |
[Genetic study on schizophrenia and its recurrence utilizing pharmacological models].
Topics: Amphetamine; Animals; Central Nervous System Stimulants; Cocaine; Disease Models, Animal; Dopamine A | 2002 |
10 trials available for ketamine and Recrudescence
Article | Year |
---|---|
Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder.
Topics: Adult; Alcohol Drinking; Alcoholism; Double-Blind Method; Female; Humans; Ketamine; Male; Recurrence | 2022 |
Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression.
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]).
Topics: Adult; Antidepressive Agents; Depression; Depressive Disorder, Major; Humans; Ketamine; Midazolam; Q | 2023 |
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.
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.
Topics: Administration, Intravenous; Adult; Antidepressive Agents; Cognition; Cognitive Behavioral Therapy; | 2017 |
Time until relapse after augmentation with single-dose ketamine in treatment-resistant depression.
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.
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.
Topics: Adult; Aged; Cross-Over Studies; Depressive Disorder, Treatment-Resistant; Dose-Response Relationshi | 2014 |
Dextromethorphan challenge in alcohol-dependent patients and controls.
Topics: Alcohol Drinking; Alcoholism; Behavior, Addictive; Dextromethorphan; Dextrorphan; Double-Blind Metho | 2000 |
21 other studies available for ketamine and Recrudescence
Article | Year |
---|---|
Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
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.
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.
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.
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.
Topics: Animals; Behavior, Animal; Conditioning, Psychological; Disease Models, Animal; Dose-Response Relati | 2008 |
Ketamine successfully terminates malignant status epilepticus.
Topics: Anesthesia, General; Anesthetics, Dissociative; Anticonvulsants; Coma; DNA Polymerase gamma; DNA-Dir | 2008 |
Ketamine-induced biliary dilatation: from Hong Kong to New York.
Topics: Abdominal Pain; Adolescent; Adult; Anesthetics, Dissociative; Asian; Bile Duct Diseases; Cholangiopa | 2012 |
Recurrent episodes of intractable laryngospasm during dissociative sedation with intramuscular ketamine.
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.
Topics: Combined Modality Therapy; Depressive Disorder, Major; Electroconvulsive Therapy; Excitatory Amino A | 2007 |
Ketamine-associated ulcerative cystitis: a new clinical entity.
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.
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.
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).
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.
Topics: Adolescent; Anesthetics, Dissociative; Cellulitis; Chi-Square Distribution; Child; Child, Preschool; | 1999 |
Effects of posterior parietal lesions on visually guided behavior in monkeys.
Topics: Animals; Female; Functional Laterality; Hand; Haplorhini; Ketamine; Macaca; Movement; Parietal Lobe; | 1978 |
[Analysis of the surgical treatment of inguinal hernias].
Topics: Anesthesia, General; Anesthesia, Local; Female; Hernia, Inguinal; Humans; Ketamine; Length of Stay; | 1986 |