Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study

Biological Psychiatry

Volumn 80, Issue 6, 2016, Pages 424-431

  Singh, Jaskaran B ^a   Fedgchin, Maggie ^a   Daly, Ella ^a   Xi, Liwen ^a   Melman, Caroline ^b   De Bruecker, Geert ^c   Tadic, Andre ^d   Sienaert, Pascal ^e   Wiegand, Frank ^a   Manji, Husseini ^a   Drevets, Wayne C ^a   Van Nueten, Luc ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b Janssen Cilag BV Netherlands   (Netherlands)

^c Psychiatric Hospital Zoete Nood Gods   (Belgium)

^d UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^e UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

Efficacy; Esketamine; Intravenous; Safety; TRD; Treatment resistant depression

Indexed keywords

ESKETAMINE; PLACEBO; KETAMINE;

ADULT; ANTIDEPRESSANT ACTIVITY; ARTICLE; CLINICAL ARTICLE; CONSTIPATION; CONTINUOUS INFUSION; CONTROLLED STUDY; DISSOCIATIVE DISORDER; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; MALE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TOOTH INFECTION; TREATMENT RESISTANT DEPRESSION; ADOLESCENT; CLINICAL TRIAL; DEPRESSIVE DISORDER, TREATMENT-RESISTANT; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; DEPRESSIVE DISORDER, TREATMENT-RESISTANT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KETAMINE; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84950154619     PISSN: 00063223     EISSN: 18732402     Source Type: Journal    
DOI: 10.1016/j.biopsych.2015.10.018     Document Type: Article

References (34)

1. 1 World Health Organization. The Global Burden of Disease: 2004 Update. 2008, World Health Organization, Geneva, Switzerland.
2. 2 Collins, P.Y., Patel, V., Joestl, S.S., March, D., Insel, T.R., Daar, A.S., et al. Grand challenges in global mental health. Nature 475 (2011), 27–30.
3. 3 Gaynes, B.N., Warden, D., Trivedi, M.H., Wisniewski, S.R., Fava, M., Rush, A.J., What did STAR*D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv 60 (2009), 1439–1445.
4. 4 Fava, M., Davidson, K.G., Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am 19 (1996), 179–200.
5. 5 Rush, A.J., Trivedi, M.H., Wisniewski, S.R., Nierenberg, A.A., Stewart, J.W., Warden, D., et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report. Am J Psychiatry 163 (2006), 1905–1917.
6. 6 Trivedi, M.H., Rush, A.J., Wisniewski, S.R., Nierenberg, A.A., Warden, D., Ritz, L., et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: Implications for clinical practice. Am J Psychiatry 163 (2006), 28–40.
7. 7 Lapidus, K.A., Soleimani, L., Murrough, J.W., Novel glutamatergic drugs for the treatment of mood disorders. Neuropsychiatr Dis Treat 9 (2013), 1101–1112.
8. 8 Murrough, J.W., Charney, D.S., Is there anything really novel on the antidepressant horizon?. Curr Psychiatry Rep 14 (2012), 643–649.
9. 9 Murrough, J.W., Ketamine as a novel antidepressant: From synapse to behavior. Clin Pharmacol Ther 91 (2012), 303–309.
10. 10 Kohrs, R., Durieux, M.E., Ketamine: Teaching an old drug new tricks. Anesth Analg 87 (1998), 1186–1193.
11. 11 Oye, I., Paulsen, O., Maurset, A., Effects of ketamine on sensory perception: Evidence for a role of N-methyl-D-aspartate receptors. J Pharmacol Exp Ther 260 (1992), 1209–1213.
12. 12 Vollenweider, F.X., Leenders, K.L., Oye, I., Hell, D., Angst, J., Differential psychopathology and patterns of cerebral glucose utilisation produced by (S)- and (R)-ketamine in healthy volunteers using positron emission tomography (PET). Eur Neuropsychopharmacol 7 (1997), 25–38.
13. 13 Murrough, J.W., Iosifescu, D.V., Chang, L.C., Al Jurdi, R.K., Green, C.E., Perez, A.M., et al. Antidepressant efficacy of ketamine in treatment-resistant major depression: A two-site randomized controlled trial. Am J Psychiatry 170 (2013), 1134–1142.
14. 14 Zarate, C.A. Jr, Singh, J.B., Carlson, P.J., Brutsche, N.E., Ameli, R., Luckenbaugh, D.A., et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry 63 (2006), 856–864.
15. 15 Mathew, S.J., Shah, A., Lapidus, K., Clark, C., Jarun, N., Ostermeyer, B., et al. Ketamine for treatment-resistant unipolar depression: Current evidence. CNS Drugs 26 (2012), 189–204.
16. 16 Mathew, S.J., Murrough, J.W., aan het Rot, M., Collins, K.A., Reich, D.L., Charney, D.S., Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: A pilot randomized, placebo-controlled continuation trial. Int J Neuropsychopharmacol 13 (2010), 71–82.
17. 17 aan het Rot, M., Collins, K.A., Murrough, J.W., Perez, A.M., Reich, D.L., Charney, D.S., et al. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry 67 (2010), 139–145.
18. 18 Murrough, J.W., Perez, A.M., Pillemer, S., Stern, J., Parides, M.K., aan het Rot, M., et al. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry 74 (2013), 250–256.
19. 19 Berman, R.M., Cappiello, A., Anand, A., Oren, D.A., Heninger, G.R., Charney, D.S., et al. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry 47 (2000), 351–354.
20. 20 DiazGranados, N., Ibrahim, L.A., Brutsche, N.E., Ameli, R., Henter, I.D., Luckenbaugh, D.A., et al. Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder. J Clin Psychiatry 71 (2010), 1605–1611.
21. 21 Ibrahim, L., Diazgranados, N., Franco-Chaves, J., Brutsche, N., Henter, I.D., Kronstein, P., et al. Course of improvement in depressive symptoms to a single intravenous infusion of ketamine vs add-on riluzole: Results from a 4-week, double-blind, placebo-controlled study. Neuropsychopharmacology 37 (2012), 1526–1533.
22. 22 Phillips, M.L., Drevets, W.C., Rauch, S.L., Lane, R., Neurobiology of emotion perception II: Implications for major psychiatric disorders. Biol Psychiatry 54 (2003), 515–528.
23. 23 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed, text rev., 2000, American Psychiatric Association, Washington, DC.
24. 24 Sheehan, D.V., Lecrubier, Y., Sheehan, K.H., Amorim, P., Janavs, J., Weiller, E., et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 59:suppl 20 (1998), 22–33 quiz 34–57.
25. 25 Corya, S.A., Williamson, D., Sanger, T.M., Briggs, S.D., Case, M., Tollefson, G., A randomized, double-blind comparison of olanzapine/fluoxetine combination, olanzapine, fluoxetine, and venlafaxine in treatment-resistant depression. Depress Anxiety 23 (2006), 364–372.
26. 26 Trivedi, M.H., Rush, A.J., Ibrahim, H.M., Carmody, T.J., Biggs, M.M., Suppes, T., et al. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: A psychometric evaluation. Psychol Med 34 (2004), 73–82.
27. 27 Montgomery, S.A., Asberg, M., A new depression scale designed to be sensitive to change. Br J Psychiatry 134 (1979), 382–389.
28. 28 Spielmans, G.I., Berman, M.I., Linardatos, E., Rosenlicht, N.Z., Perry, A., Tsai, A.C., Adjunctive atypical antipsychotic treatment for major depressive disorder: A meta-analysis of depression, quality of life, and safety outcomes. PLoS Med, 10, 2013, e1001403.
29. 29 Geisslinger, G., Hering, W., Thomann, P., Knoll, R., Kamp, H.D., Brune, K., Pharmacokinetics and pharmacodynamics of ketamine enantiomers in surgical patients using a stereoselective analytical method. Br J Anaesth 70 (1993), 666–671.
30. 30 Persson, J., Hasselstrom, J., Maurset, A., Oye, I., Svensson, J.O., Almqvist, O., et al. Pharmacokinetics and non-analgesic effects of S- and R-ketamines in healthy volunteers with normal and reduced metabolic capacity. Eur J Clin Pharmacol 57 (2002), 869–875.
31. 31 Petrakis, I.L., Limoncelli, D., Gueorguieva, R., Jatlow, P., Boutros, N.N., Trevisan, L., et al. Altered NMDA glutamate receptor antagonist response in individuals with a family vulnerability to alcoholism. Am J Psychiatry 161 (2004), 1776–1782.
32. 32 Krystal, J.H., Karper, L.P., Seibyl, J.P., Freeman, G.K., Delaney, R., Bremner, J.D., et al. Subanesthetic effects of the noncompetitive NMDA antagonist, ketamine, in humans. Psychotomimetic, perceptual, cognitive, and neuroendocrine responses. Arch Gen Psychiatry 51 (1994), 199–214.
33. 33 Morgan, C.J., Muetzelfeldt, L., Curran, H.V., Consequences of chronic ketamine self-administration upon neurocognitive function and psychological wellbeing: A 1-year longitudinal study. Addiction 105 (2010), 121–133.
34. 34 Lapidus, K.A., Levitch, C.F., Perez, A.M., Brallier, J.W., Parides, M.K., Soleimani, L., et al. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry 76 (2014), 970–976.