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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- 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 · 2014: 1
- 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 › 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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