Low-dose ketamine for treatment resistant depression in an academic clinical practice setting
This open-label retrospective study (n=41) evaluated the efficacy and safety of intravenous ketamine (35mg/70kg) infusion in a sample of patients who had treatment-resistant depression (TRD) and were being treated in a ‘naturalistic’ clinical context. Low-dose ketamine was efficacious and generally well-tolerated in the sample population, as participants reported improvements in depressive symptoms with a 53.7% response rate 24 hours post-infusion.
Authors
- Benjamin Malcolm
- David Feifel
Published
Abstract
Background
Recent studies demonstrating a rapid, robust improvement in treatment resistant depression (TRD) following a single sub-anesthetic infusion of ketamine have generated much excitement. However, these studies are limited in their generalizability to the broader TRD population due to their subject exclusion criteria which typically limit psychiatric comorbidity, concurrent medication, and level of suicide risk. This paper describes the safety and efficacy of sub-anesthetic ketamine infusions in a naturalistic TRD patient sample participating in a real-world TRD treatment program within a major university health system.
Methods
The effects of a sub-anesthetic dose (0.5 mg/kg) of ketamine infused IV over forty minutes on TRD patients participating in a treatment program at the University of California, San Diego was investigated by retrospectively analyzing the medical charts of 41 adult TRD patients with a diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD).
Results
Subjects were aged 48.6, 78% white, 36.6% female, and 82.9% had MDD. Significant psychiatric comorbidity existed in 73%. Average pre-infusion BDI score was 32.6 ± 8.4 (S.D) and dropped to 16.8 ± 3.1 at 24-h post-infusion (p < 0.001). The 24-h response (≥ 50% reduction from pre-infusion) and remission (BDI <13) rates were 53.7% and 41.5%, respectively. Three quarters of responders maintained responder status at 7-days. Ketamine infusions were well tolerated with occasional nausea or anxiety and mild hemodynamic effects during the infusion.
Limitations
Retrospective nature of this study, lack of control group and use of self-report depression ratings scales.
Conclusions
This is the first published study of sub-anesthetic ketamine infusions in a real-world TRD population. The results suggest that this treatment is effective and well tolerated in this population
Research Summary of 'Low-dose ketamine for treatment resistant depression in an academic clinical practice setting'
Introduction
Clinical depression is common and disabling, and a substantial minority of patients fail to respond to multiple standard antidepressant trials. Earlier research shows that a single sub‑anesthetic intravenous infusion of ketamine can produce rapid antidepressant effects in treatment‑resistant depression (TRD), with aggregated response rates around 61% in published randomised and open‑label studies. However, most of those prospective trials applied strict inclusion and exclusion criteria that limited psychiatric comorbidity, concurrent medications and suicide risk, raising concerns about the generalisability of their findings to routine clinical populations. This paper reports a retrospective analysis of outcomes following a single 0.5 mg/kg, 40‑minute intravenous ketamine infusion delivered in an outpatient academic clinical programme at the University of California, San Diego. Feifel and colleagues set out to examine the safety and efficacy of that initial infusion in a ‘‘naturalistic’’ TRD sample that included prevalent comorbidities and concurrent psychotropic medications, using self‑reported Beck Depression Inventory (BDI) scores at baseline, 1‑hour, 24‑hours and, when available, 7‑days post‑infusion as the primary outcome measures. The study aims to assess real‑world response and tolerability outside the constraints of typical clinical trials.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- Authors
- APA Citation
Feifel, D., Malcolm, B., Boggie, D., & Lee, K. (2017). Low-dose ketamine for treatment resistant depression in an academic clinical practice setting. Journal of Affective Disorders, 221, 283-288. https://doi.org/10.1016/j.jad.2017.06.043
References (5)
Papers cited by this study that are also in Blossom
Berman, R. M., Cappiello, A., Anand, A. et al. · Biological Psychiatry (2000)
Coyle, C. M., Laws, K. R. · Human Psychopharmacology (2015)
Kraus, C., Rabl, U., Vanicek, T. et al. · International Journal of Psychiatry in Clinical Practice (2017)
Sos, P., Klirova, M., Novák, T. et al. · Neuropsychiatric Disease And Treatment (2013)
Zarate, C. A., Brutsche, N. E., Ibrahim, L. et al. · Biological Psychiatry (2012)
Cited By (2)
Papers in Blossom that reference this study
Basso, L., Bönke, L., Aust, S. et al. · Journal of Psychiatric Research (2020)
Ho, J. T., Preller, K. H., Lenggenhager, B. · Neuroscience and Biobehavioral Reviews (2020)
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