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Safety and Tolerability of IV Ketamine in Adults with Major Depressive Or Bipolar Disorder: Results from the Canadian Rapid Treatment Center of Excellence

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Safety and Tolerability of IV Ketamine in Adults with Major Depressive Or Bipolar Disorder: Results from the Canadian Rapid Treatment Center of Excellence Expert Opinion on Drug Safety ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/ieds20 Safety and tolerability of IV ketamine in adults with major depressive or bipolar disorder: results from the Canadian rapid treatment center of excellence Nelson B. Rodrigues , Roger S. McIntyre , Orly Lipsitz , Yena Lee , Danielle S. Cha , Flora Nasri , Hartej Gill , Leanna M.W. Lui , Mehala Subramaniapillai , Kevin Kratiuk , Kangguang Lin , Roger Ho , Rodrigo B. Mansur & Joshua D. Rosenblat To cite this article: Nelson B. Rodrigues , Roger S. McIntyre , Orly Lipsitz , Yena Lee , Danielle S. Cha , Flora Nasri , Hartej Gill , Leanna M.W. Lui , Mehala Subramaniapillai , Kevin Kratiuk , Kangguang Lin , Roger Ho , Rodrigo B. Mansur & Joshua D. Rosenblat (2020) Safety and tolerability of IV ketamine in adults with major depressive or bipolar disorder: results from the Canadian rapid treatment center of excellence, Expert Opinion on Drug Safety, 19:8, 1031-1040, DOI: 10.1080/14740338.2020.1776699 To link to this article: https://doi.org/10.1080/14740338.2020.1776699 View supplementary material Published online: 15 Jun 2020. Submit your article to this journal Article views: 449 View related articles View Crossmark data Citing articles: 6 View citing articles Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=ieds20 EXPERT OPINION ON DRUG SAFETY 2020, VOL. 19, NO. 8, 1031–1040 https://doi.org/10.1080/14740338.2020.1776699 ORIGINAL RESEARCH Safety and tolerability of IV ketamine in adults with major depressive or bipolar disorder: results from the Canadian rapid treatment center of excellence Nelson B. Rodrigues a,b, Roger S. McIntyrea,b,c,d, Orly Lipsitza,b, Yena Leea,b, Danielle S. Cha a, Flora Nasria, Hartej Gilla,b, Leanna M.W. Luia, Mehala Subramaniapillaia,b, Kevin Kratiukb, Kangguang Line,f, Roger Hog, Rodrigo B. Mansura,d and Joshua D. Rosenblata,b,c,d aMood Disorders Psychopharmacology Unit, University Health Network; University of Toronto, Toronto, ON, Canada; bCanadian Rapid Treatment Center of Excellence, Mississauga, ON, Canada; cBrain and Cognition Discovery Foundation, Canada; University of Toronto, Toronto, ON, Canada; dDepartment of Psychiatry, University of Toronto, Toronto, ON, Canada; eDepartment of Affective Disorder, The Affiliated Brain Hospital of Guangzhou Medical University, (Guangzhou Huiai Hospital), Guangzhou Medical University, Guangzhou, China; fLaboratory of Emotion and Cognition, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou Medical University, Guangzhou, China; gDepartment of Psychological Medicine, National University of Singapore, Singapore ABSTRACT ARTICLE HISTORY Objectives: Rigorous clinical trials suggest ketamine is safe and well-tolerated in patients with treat­ Received 29 April 2020 ment-resistant depression (TRD). There is a paucity of data on the safety and tolerability of ketamine in Accepted 28 May 2020 community-based clinics treating patients with TRD. Methods: Retrospective data was analyzed from 203 patients with TRD who received repeat-dose IV KEYWORDS Ketamine; treatment- ketamine. Safety was operationalized as hemodynamic changes. Tolerability was evaluated through the resistant depression; major reporting of adverse events and dissociation symptom severity, as measured by the Clinician- depressive disorder; bipolar Administered Dissociative States Scale. disorder; tolerability; safety Results: Ketamine was well-tolerated, with less than 5% of patients withdrawing due to tolerability concerns. Blood pressure significantly increased during infusion, with 44.3% meeting criteria for treat­ ment-emergent hypertension (i.e., blood pressure ≥ 165/100 mmHg). 12% of patients exhibiting hypertension required pharmacological intervention. The most frequently reported adverse events included drowsiness (56.4%), dizziness (45.2%), dissociation (35.6%), and nausea (13.3%). Dissociation severity significantly attenuated after the first infusion, but plateaued for subsequent infusions. Conclusion: Intravenous ketamine was safe and well-tolerated. Hypertension was commonly observed and was often transient. Dissociation was most frequently reported after the first infusion but remained a consistent but not treatment-limiting adverse event thereafter. No patients exhibited psychosis, mania, or new onset suicidality with IV ketamine. 1. Introduction randomized controlled trials indicate that ketamine is gener­ ally well tolerated and is safe [8,9]. The most frequently Major depressive disorder (MDD) is a leading cause of dis­ reported treatment-emergent adverse events and safety con­ ability in both high- and low-income countries [1]. The cerns include dissociation, nausea, blood pressure elevation, majority of individuals with MDD receiving conventional tachycardia, and headache [9]. antidepressants do not achieve full syndromal recovery, Patients receiving sub-anesthetic doses of ketamine contributing to the illness burden [2,3]. The dissociative describe sensations of depersonalization, derealization, dis­ anesthetic and N-Methyl-D-Aspartate (NMDA) receptor tortions of time or space, and transient amnesia [10]. The antagonist, ketamine, has demonstrated rapid and robust medication also has sympathomimetic effects on the cardio­ efficacy in adults who have not experienced sufficient syn­ vascular system, thereby increasing heart rate and blood dromal relief following multiple antidepressant treatment pressure [11,12]. As a result, blood pressure and heart rate trials (i.e., treatment-resistant depression [TRD]) [4–7]. must be carefully monitored during ketamine administration Notwithstanding the relatively well-established antidepres­ to avoid cardiovascular complications. Notably, the risk of sant efficacy of ketamine in TRD, as well as preliminary evi­ respiratory depression is lower with ketamine than with dence supporting its anti-suicidality effects, the safety and other anesthetics and sedatives [13]. Other frequently tolerability of long-term ketamine treatment is insufficiently reported adverse events included drowsiness, dizziness, nau­ characterized. Results from short-term (i.e., < 2 weeks) sea and vomiting [12]. CONTACT Roger S. McIntyre [email protected] University Health Network, Toronto, ON M5T 2S8, Canada Trial registration: NCT04209296 This article was originally published with errors, which have now been corrected in the online version. Please see Correction (http://dx.doi.org/10.1080/14740338. 2020.1791515) Supplemental data for this article can be accessed here. © 2020 Informa UK Limited, trading as Taylor & Francis Group 1032 N. B. RODRIGUES ET AL. Herein, we sought to determine the safety and tolerability not to take any medications six hours prior to the infusion and of intravenous (IV) ketamine after repeat dose administration four hours after infusion. in an outpatient clinic providing care to adults with TRD. Given that extant data were derived from small clinical trial samples, 2.2. Ketamine administration protocol the impetus for this analysis is provided by the need for real- world safety and tolerability data on a large sample of patients Patients received a total of four infusions over one-to-two representative of TRD. weeks. The first two infusions were dosed at 0.5 mg/kg. If patients experienced a suboptimal response to ketamine (as determined by the Quick Inventory for Depressive 2. Patients and methods Symptomatology-Self Report 16-item), they were given the option to increase their dose to 0.75 mg/kg for the remaining 2.1. Participants and study design two infusions. Patients remained at the index dose if they Patients included in this post-hoc analysis received repeat- experienced a clinically significant antidepressant effect (i.e., dose IV ketamine infusions at the Canadian Rapid Treatment ≥20% improvement in depression scores), had difficulty toler­ Center of Excellence (CRTCE) in Mississauga, Ontario, Canada, ating the index dose, or if they preferred to remain at the between July 2018 and December 2019. The CRTCE is the lower dose. All infusions were administered by an anesthesiol­ premier clinic in Canada to provide IV ketamine, outside of ogist, who diluted the medication into 0.9% saline solution clinical trials, as a treatment for adults (aged ≥ 18 years) with and administered the treatment over 40–45 minutes. Patients TRD. Ketamine has not received approval for its use outside of were then monitored by nursing staff until the acute effects of anesthesia. As such, the cost of infusion is the responsibility of ketamine subsided (up to two hours) and they were safe to be the patient or paid via private insurance plans for treatment. discharged. Individuals were referred to the CRTCE by primary care physicians, psychiatrists, or nurse practitioners. The primary 2.3. Systematic adverse event monitoring focus of the clinic was to treat intractable depressive symp­ toms, within the context of MDD and BD. Patients presenting Prior to the start of infusion, patient baseline blood pressure, with post-traumatic stress disorder (PTSD) and obsessive- heart rate and standard telemetry (i.e., respiratory rate and compulsive disorder (OCD) were also eligible for treatment, oximetry) were collected by anesthesiologists. Patient safety as long as a depressive episode was the chief complaint. In was continually monitored and recorded at 5-minute intervals order to be eligible, patients must meet Stage 2 treatment throughout
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