Dissociative symptoms with intravenous ketamine in treatment-resistant depression exploratory observational study
A. Włodarczyk, Wiesław Jerzy Cubała, Maria Gałuszko‐węgielnik, Joanna Szarmach
Medicine July 23, 2021 DOI: 10.1097/md.0000000000026769 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Naturalistic observational study Peer reviewed |
|---|---|
| Sample size | 49 |
| Population | Inpatients with major depressive disorder and bipolar disorder with treatment-resistant depression |
| Intervention | ketamine intravenous infusions |
| Dose | 0.5 mg/kg |
| Duration | Eight infusions, each 40 minutes, with follow-up within 1 hour post-infusion |
| Topics | Depression Esketamine Ketamine |
| Citations | 23 |
| Registration | NCT04226963 |
| Key findings | Intravenous ketamine as an add-on treatment had a good safety profile, with dissociative symptoms resolving quickly and no association between dissociation and treatment outcome. |
Abstract
Abstract There is evidence for ketamine use in treatment-resistant depression (TRD). Several safety and tolerability concerns arise regarding adverse drug reactions and specific subpopulations. This paper aims to investigate the relationship between dissociative and psychometric measures in course of intravenous ketamine treatment in TRD inpatients with major depressive disorder and bipolar disorder. This study result represents safety data in a population of 49 inpatients with major depressive disorder and bipolar disorder subjects receiving eight 0.5 mg/kg of ketamine intravenous infusions, with a duration of 40 min each, as an add-on treatment to standard-of-care pharmacotherapy, registered in the naturalistic observational protocol of the tertiary reference unit for mood disorders (NCT04226963). The safety psychometrics assessed dissociation and psychomimetic symptomatology with the Clinician-Administered Dissociative States Scale (CADSS) the Brief Psychiatric Rating Scale (BPRS). The significant differences in CADSS scores between measurements in course of the treatment were observed (P = .003). No significant differences between BPRS measurements were made after infusions. In each case, both BPRS and CADSS values dropped to the “absent” level within 1 hour from the infusion. Neither CADSS nor BPRS scores were associated with the treatment outcome. The study demonstrates a good safety profile of intravenous ketamine as an add-on intervention to current psychotropic medication in TRD. The abatement of dissociation was observed in time with no sequelae nor harm. The study provides no support for the association between dissociation and treatment outcome. This study may be underpowered due to the small sample size. The protocol was defined as a study on acute depressive symptomatology without blinding.
Comparable studies
Other observational and cohort studies on ketamine for depression, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Concomitant BDNF and sleep slow wave changes indicate ketamine-induced plasticity in major depressive disorder Patients with treatment-resistant major depressive disorder | 2012 | Observational cohort | n = 30 |
| Altered peripheral immune profiles in treatment-resistant depression: response to ketamine and prediction of treatment outcome Healthy controls and actively depressed patients with treatment-resistant depression... | 2017 | Observational cohort | n = 59 |
| Clinical Predictors of Ketamine Response in Treatment-Resistant Major Depression Treatment-resistant inpatients with DSM-IV-TR-diagnosed major depressive disorder or... | 2014 | Post hoc analysis of pooled data from four studies | n = 108 |
| An investigation of amino-acid neurotransmitters as potential predictors of clinical improvement to ketamine in depression Drug-free patients with major depressive disorder | 2011 | Observational cohort | n = 14 |
| Efficacy of ketamine therapy in the treatment of depression Drug-free/naïve men with severe depression, no history of psychotic disorder, head... | 2019 | Observational cohort | n = 25 |