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A double-blind, randomized, placebo-controlled, dose-frequency study of intravenous ketamine in patients with treatment-resistant depression.
Open accessAbstract
OBJECTIVE: Ketamine, an N-methyl-d-aspartate glutamate receptor antagonist, has demonstrated a rapid-onset antidepressant effect in patients with treatment-resistant depression. This study evaluated the efficacy of twice- and thrice-weekly intravenous administration of ketamine in sustaining initial antidepressant effects in patients with treatment-resistant depression. METHOD: In a multicenter, double-blind study, adults (ages 18-64 years) with treatment-resistant depression were randomized to receive either intravenous ketamine (0.5 mg/kg of body weight) or intravenous placebo, administered over 40 minutes, either two or three times weekly, for up to 4 weeks. Patients who discontinued double-blind treatment after at least 2 weeks for lack of efficacy could enter an optional 2-week open-label phase to receive ketamine with the same frequency as in the double-blind phase. The primary outcome measure was change from baseline to day 15 in total score on the Montgomery-Åsberg Depression Rating Scale (MADRS). RESULTS: In total, 67 (45 women) of 68 randomized patients received treatment. In the twice-weekly dosing groups, the mean change in MADRS score at day 15 was -18.4 (SD=12.0) for ketamine and -5.7 (SD=10.2) for placebo; in the thrice-weekly groups, it was -17.7 (SD=7.3) for ketamine and -3.1 (SD=5.7) for placebo. Similar observations were noted for ketamine during the open-label phase (twice-weekly, -12.2 [SD=12.8] on day 4; thrice-weekly, -14.0 [SD=12.5] on day 5). Both regimens were generally well tolerated. Headache, anxiety, dissociation, nausea, and dizziness were the most common (≥20%) treatment-emergent adverse events. Dissociative symptoms occurred transiently and attenuated with repeated dosing. CONCLUSIONS: Twice-weekly and thrice-weekly administration of ketamine at 0.5 mg/kg similarly maintained antidepressant efficacy over 15 days.
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ANÁLISE DO USO DA INFUSÃO DE CETAMINA EM PACIENTES COM DEPRESSÃO GRAVE
Soares, L. E. V., Borges, G. V. D. S., de Andrade, M. L. A., Albuquerque, A. M. D. L., de Sousa, L. C. A., de Mélo, J. R. P. C., Naves, S. V., Vitorio, L. D. A., Ramos, A. P. Q., França, F. O. S., et al. (2024) · Brazilian Journal of Implantology and Health Sciences · doi:10.36557/2674-8169.2024v6n8p2223-2239
Chapter 9. Pharmacotherapy for Pediatric Depression
Kim, G.-M., Gandhi, R., & Cullen, K. R. (2019) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615379200.lg09
Chapter 22. Ketamine and Other Investigational Agents
(2022) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615379620.lg22
Terao, I., & Kodama, W. (2024) · Psychiatry and Clinical Neurosciences Reports · doi:10.1002/pcn5.70042
Current Treatments for Depression
D, M. F. M., & Krystal, J. H. (2025) · Oxford University Press eBooks · doi:10.1093/med/9780197640654.003.0034
Metadata
- Authors
- Singh, J. B., Fedgchin, M., Daly, E. J., De Boer, P., Cooper, K., Lim, P., Pinter, C., Murrough, J. W., Sanacora, G., Shelton, R. C., Kurian, B., Winokur, A., Fava, M., Manji, H., Drevets, W. C., & Van Nueten, L.
- Affiliations
- University of Alabama at Birmingham (US)
- From Janssen Research and Development, Titusville, N.J., and Beerse, Belgium; the Departments of Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, N.Y.; the Department of Psychiatry, Yale University, New Haven, Conn.; the Department of Psychiatry and Behavioral Neurobiology, School of Medicine, University of Alabama at Birmingham; the Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas; the Institute of Living, Hartford, Conn.; University of...
- ORCID
- Venue
- American Journal of Psychiatry
- Published
- 2016-08-01
- Volume
- 173
- Issue
- 8
- Pages
- 816-826
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- OpenAlex
- W2330587564
- Semantic Scholar
- 2883380785205ffb1f72303d5b51284fb5d21c95
- Cited by
- 525
- References
- 20
- Citations by year
- 2026: 23 · 2025: 47 · 2024: 47 · 2023: 51 · 2022: 65 · 2021: 65 · 2020: 72 · 2019: 47 · 2018: 49 · 2017: 38 · 2016: 19
- FWCI
- 41.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Novartis
- Sanofi
- Yale University
- Biogen
- Teva Pharmaceutical Industries
- F. Hoffmann-La Roche
- Stanley Medical Research Institute
- Icahn School of Medicine at Mount Sinai
- Sunovion
- Indivior
- Cerecor
- American Society of Clinical Psychopharmacology
- FORUM Pharmaceuticals
- Belvoir Media Group
- Vistagen Therapeutics
- Servier
- H. Lundbeck A/S
- National Institutes of Health
- Genentech
- St. Jude Medical
- Allergan
- National Institute of Mental Health
- National Institute on Drug Abuse
- National Center for Complementary and Alternative Medicine
- Janssen Research and Development
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Life Sciences › Neuroscience › Biological Psychiatry › Tryptophan and brain disorders
- Keywords
- ketamine, treatment-resistant depression, intravenous administration, dosing frequency, antidepressant efficacy, NMDA receptor antagonists, dissociation, adverse events, open-label extension
- MeSH terms
- Adolescent, Adult, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Humans, Infusions, Intravenous, Ketamine, Middle Aged, Psychiatric Status Rating Scales, Psychometrics, Young Adult, Depressive Disorder, Treatment-Resistant
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