Repeated intranasal ketamine for treatment-resistant depression – the way to go? Results from a pilot randomised controlled trial

Journal of Psychopharmacology

Volumn 32, Issue 4, 2018, Pages 397-407

  Gálvez, Verònica ^a,b   Li, Adrienne ^a   Huggins, Christina ^a   Glue, Paul ^c   Martin, Donel ^a,b   Somogyi, Andrew A ^d   Alonzo, Angelo ^a,b   Rodgers, Anthony ^e   Mitchell, Philip B ^a,b   Loo, Colleen K ^a,b,f,g  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b BLACK DOG INSTITUTE   (Australia)

^c UNIVERSITY OF OTAGO   (New Zealand)

^d UNIVERSITY OF ADELAIDE   (Australia)

^e UNIVERSITY OF SYDNEY   (Australia)

^f WESLEY HOSPITAL   (Australia)

^g ST GEORGE HOSPITAL   (Australia)

Author keywords

adverse effects; efficacy; intranasal spray; Ketamine; randomised controlled trial; treatment resistant depression

Indexed keywords

ANALGESIC AGENT; ANTIDEPRESSANT AGENT; KETAMINE; MIDAZOLAM; NORKETAMINE;

ADULT; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; INTRANASAL DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; MALE; MIDDLE AGED; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESISTANT DEPRESSION;

ADMINISTRATION, INTRANASAL; ADMINISTRATION, INTRAVENOUS; ADULT; ANALGESICS; ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, TREATMENT-RESISTANT; DOUBLE-BLIND METHOD; FEMALE; HUMANS; KETAMINE; MALE; MIDAZOLAM; MIDDLE AGED; PILOT PROJECTS; TREATMENT OUTCOME;

EID: 85044059305     PISSN: 02698811     EISSN: 14617285     Source Type: Journal    
DOI: 10.1177/0269881118760660     Document Type: Article

References (36)

1. Aan het Rot M, Collins KA, Murrough JW. (2010) Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry 67: 139–145.
2. Andrade C, (2015) Intranasal drug delivery in neuropsychiatry: Focus on intranasal ketamine for refractory depression. J Clin Psychiatry 76: 628–631.
3. Berman RM, Cappiello A, Anand A. (2000) Antidepressant effects of ketamine in depressed patients. Biol Psychiatry 47: 351–354.
4. Bradfield A, (1965) Reservations on the safety of oxytocin nasal spray in obstetrics. Aust N Z J Obstet Gynaecol 5: 138–143.
5. Bremner JD, Krystal JH, Putnam FW. (1998) Measurement of dissociative states with the Clinician-Administered Dissociative States Scale (CADSS). J Trauma Stress 11: 125–136.
6. Daly E, Singh J, Fedgchin M. (2016) Intranasal esketamine in treatment resistant depression – a double-blind, randomized, efficacy and dose response study. In: 71st Society of Biological Psychiatry annual meeting, 12–14 May, Atlanta, Georgia, USA, 2016.
7. Diazgranados N, Ibrahim L, Brutsche NE. (2010) A randomized add-on trial of an N-methyl-d-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry 67: 793–802.
8. Djupesland G, (2013) Nasal drug delivery devices: Characteristics and performance in a clinical perspective—a review. Drug Deliv Transl Res 3: 42–62.
9. Glue P, Loo C, Rodgers A. (2017) Comments on Cooper et al.’s review on strategies to mitigate dissociative and psychotomimetic effects from ketamine when used as a fast-acting antidepressant. World J Biol Psychiatry 18: 489.
10. Guastella AJ, Hickie IB, McGuinness MM. (2013) Recommendations for the standardisation of oxytocin nasal administration and guidelines for its reporting in human research. Psychoneuroendocrinology 38: 612–625.
11. Humphrey L, Arbuckle R, Moldwin R. (2012) The bladder pain/interstitial cystitis symptom score: development, validation, and identification of a cut score. Eur Urol 61: 271–279.
12. Hu YD, Xiang YT, Fang JX. (2016) Single i.v. ketamine augmentation of newly initiated escitalopram for major depression: results from a randomized, placebo-controlled 4-week study. Psychol Med 46: 623–635.
13. Kushwaha SKS, Keshari RK, Rai AK, (2011) Advances in nasal trans-mucosal drug delivery. J Appl Pharm Sci 1: 21–28.
14. Lai R, Katalinic N, Glue P. (2014) Pilot dose-response trial of i.v. ketamine in treatment-resistant depression. World J Biol Psychiatry 15: 579–584.
15. Lapidus KA, Levitch CF, Perez AM. (2014) A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry 76: 970–976.
16. Loo CK, Galvez V, O’Keefe E. (2016) Placebo-controlled pilot trial testing dose titration and intravenous, intramuscular and subcutaneous routes for ketamine in depression. Acta Psychiatr Scand 134: 48–56.
17. Luckenbaugh DA, Niciu MJ, Ionescu DF. (2014) Do the dissociative side effects of ketamine mediate its antidepressant effects? J Affect Disord 159: 56–61.
18. McGirr A, Berlim MT, Bond DJ. (2015) A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med 45: 693–704.
19. Montgomery SA, Asberg M, (1979) A new depression scale designed to be sensitive to change. Br J Psychiatry 134: 382–389.
20. Murrough JW, Iosifescu DV, Chang LC. (2013a) Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry 170: 1134–1142.
21. Murrough JW, Perez AM, Pillemer S. (2013b) Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry 74: 250–256.
22. Posner K, Brown GK, Stanley B. (2011) The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 168: 1266–1277.
23. Pouget P, Wattiez N, Rivaud-Pechoux S. (2010) Rapid development of tolerance to sub-anaesthetic dose of ketamine: an oculomotor study in macaque monkeys. Psychopharmacology (Berl) 209: 313–318.
24. Rasmussen KG, Lineberry TW, Galardy CW. (2013) Serial infusions of low-dose ketamine for major depression. J Psychopharmacol 27: 444–450.
25. Rush AJ, Fava M, Wisniewski SR. (2004) Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials 25: 119–142.
26. Sackeim HA, (2001) The definition and meaning of treatment-resistant depression. J Clin Psychiatry 62(Suppl 16): 10–17.
27. Segmiller F, Ruther T, Linhardt A. (2013) Repeated S-ketamine infusions in therapy resistant depression: a case series. J Clin Pharmacol 53: 996–998.
28. Shafer A, (2005) Meta-analysis of the brief psychiatric rating scale factor structure. Psychol Assess 17: 324–335.
29. Shiroma PR, Johns B, Kuskowski M. (2014) Augmentation of response and remission to serial intravenous subanesthetic ketamine in treatment resistant depression. J Affect Disord 155: 123–129.
30. Sos P, Kirova M, Novak T. (2013) Relationship of ketamine’s antidepressant and psychomimetic effects in unipolar depression. Neuroendocrinology Letters 34: 287–293.
31. Xu Y, Hackett M, Carter G. (2016) Effects of low-dose and very low-dose ketamine among patients with major depression: a systematic review and meta-analysis. Int J Neuropsychopharmacol 19: pii: pyv124.
32. Yanagihara Y, Ohtani M, Kariya S. (2003) Plasma concentration profiles of ketamine and norketamine after administration of various ketamine preparations to healthy Japanese volunteers. Biopharm Drug Dispos 24: 37–43.
33. Young RC, Biggs JT, Ziegler VE. (1978) A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 133: 429–435.
34. Zanos P, Moaddel R, Morris PJ. (2016) NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature 533: 481–486.
35. Zarate CA, Jr Brutsche NE, Ibrahim L. (2012) Replication of ketamine’s antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry 71: 939–946.
36. Zarate CA, Jr Singh JB, Carlson PJ. (2006) A randomized trial of an N-methyl-d-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry 63: 856–864.