Cited by 433Treatment of Major DepressionElectroconvulsive Therapy StudiesTryptophan and brain disorders

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Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD)

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Fava, Maurizio, Freeman, Marlene P., Flynn, Martina, Judge, Heidi, Hoeppner, Bettina B., Cusin, Cristina, Ionescu, Dawn F., Mathew, Sanjay J., Chang, Lee C., Iosifescu, Dan V., Murrough, James, Debattista, Charles, Schatzberg, Alan F., Trivedi, Madhukar H., Jha, Manish K, Sanacora, Gerard, Wilkinson, Samuel T., Papakostas, George I.·2020·Molecular Psychiatry

DOI 10.1038/s41380-018-0256-5PMC PMC6447473

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Abstract

Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.

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“On the other hand, some clinical studies failed to replicate the association between psychotomimetic and antidepressant effects [62, 63].”
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Bera, K., Looger, L. L., Proekt, A., & Cichon, J. (2025) · The Neuroscientist · doi:10.1177/10738584251403946 · Cited by 9
“In a dose-response study, Fava et al (2020) evaluated the antidepressant efficacy of various subanesthetic intravenous ketamine doses (0.1, 0.2, 0.5, and 1.0 mg/kg) versus active placebo (midazolam) in treatment-resistant depression.”
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Ketamine Infusions and Rapid Reduction of Suicidal and Depressive Symptoms in Major Depressive Episode
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Loss of the sustained antidepressant-like effect of (2R,6R)-hydroxynorketamine in NMDA receptor GluN2D subunit knockout mice
Yamagishi, A., Ikekubo, Y., Mishina, M., Ikeda, K., & Ide, S. (2024) · Journal of Pharmacological Sciences · doi:10.1016/j.jphs.2024.01.008 · Cited by 7
A scientometric analysis of research on the role of NMDA receptor in the treatment of depression
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Apnea during slow sub-anaesthetic infusion of intravenous ketamine for treatment-resistant depression
Gómez‐Revuelta, M., Fernández-Rodríguez, M., Antón, L. B., & Vázquez-Bourgón, J. (2020) · Therapeutic Advances in Psychopharmacology · doi:10.1177/2045125320981498 · Cited by 7
Preventive effect of a Kampo medicine, kososan, on recurrent depression in a mouse model of repeated social defeat stress
Ito, N., Sasaki, K., Hirose, E., Nagai, T., Isoda, H., & Odaguchi, H. (2021) · Gene · doi:10.1016/j.gene.2021.145920 · Cited by 7
Online news media reporting of ketamine as a treatment for depression from 2000 to 2017
Gallagher, B., Neiman, A., Slattery, M.-C., & McLoughlin, D. M. (2021) · Irish Journal of Psychological Medicine · doi:10.1017/ipm.2021.47 · Cited by 7
“Ketamine has also been reported to be effective at various sub-anaesthetic doses, suggesting that there is a range of effective doses and routes that merits further investigation with larger participant numbers (Andrade, 2017; Fava et al .”
Background
Efficacy of addition of the anti-inflammatory, IV glutathione to standard ketamine IV therapy in major depressive disorder
Eshkevari, L., Sales, M. A. M., Collins, C., Totoraitis, J., Donohue, L., Dalley, C. B., Bregman, B., Negro, P., Gordon, S., & Estrada, C. (2024) · Psychiatry Research · doi:10.1016/j.psychres.2024.115949 · Cited by 6
Ketamine attenuates kidney damage and depression-like behaviors in mice with cisplatin-induced acute kidney injury
Huang, T., He, Y., Cheng, R., Zhang, Q., Zhong, X., Hashimoto, K., Liu, Y., & Pu, Y. (2024) · Translational Psychiatry · doi:10.1038/s41398-024-03176-4 · Cited by 7
A systematic review of ketamine and esketamine-induced long-term potentiation and synaptic scaling: Do the molecular and synaptic plasticity effects inform dosing intervals?
Le, G. H., Wong, S., Johnson, D. E., Lu, A., Orsini, D. K., Chisamore, N., Luch, S. D. D., Rosenblat, J. D., & McIntyre, R. S. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.121081 · Cited by 6
Ketamine and other Glutamate Receptor Modulating Agents for Treatment-Resistant Depression: A Systematic Review of Randomized Controlled Trials
Shamabadi, A., Ahmadzade, A., Aqamolaei, A., Mortazavi, S. H., Hasanzadeh, A., & Akhondzadeh, S. (2022) · Iranian Journal of Psychiatry · doi:10.18502/ijps.v17i3.9733 · Cited by 9
“doses were significantly superior to placebo (25).”
Polish standard of treatment with racemic ketamine for patients with depressive disorders developed by a Working Group appointed by the National Consultant in the field of psychiatry
Gałecki, P., Bliźniewska-Kowalska, K. M., Cubała, W. J., Depukat, A., Mosiołek, A., RYBAKOWSKI, J. K., Samochowiec, J., Sobolewski, B., Szulc, A., & Dudek, D. (2024) · Psychiatria Polska · doi:10.12740/pp/189494 · Cited by 9
Repeated administration of esketamine ameliorates mechanical allodynia in mice with chemotherapy-induced peripheral neuropathy: A role of gut microbiota and metabolites
Luan, W.-W., Gu, H., Qiu, D., Ding, X., Liu, P., Hashimoto, K., Yang, J., & Wang, X. (2025) · Neurochemistry International · doi:10.1016/j.neuint.2025.105961 · Cited by 6
Ketamine as an adjunctive therapy for major depression - a randomised controlled pragmatic pilot trial (Karma-Dep Trial)
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Ketamine for acute catatonia: A case report
Kobayashi, B. (2021) · Current Psychiatry · doi:10.12788/cp.0132 · Cited by 6
Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants
Yavorsky, C., Ballard, E. D., Opler, M. G. A., Sedway, J. A., Targum, S. D., & Lenderking, W. R. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1135828 · Cited by 7
“In two clinical trials of RAADs, HAMD6 scores improved significantly more than placebo assigned subjects (37, 38).”
Background
Psychedelics and the Neurobiology of Meaningfulness
Krystal, J. H., Preller, K. H., Corlett, P. R., Anticevic, A., & Kaye, A. P. (2023) · Biological Psychiatry Cognitive Neuroscience and Neuroimaging · doi:10.1016/j.bpsc.2023.09.003 · Cited by 6
Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2])
Jelovac, A., McCaffrey, C., Terao, M., Shanahan, E., Mohamed, E., Whooley, E., McDonagh, K., McDonogh, S., Igoe, A., Loughran, O., et al. (2023) · BMC Psychiatry · doi:10.1186/s12888-023-05365-9 · Cited by 5
“A 40-minute 0.5 mg/kg of body weight IV infusion has been the most effective dose to date for both unipolar and bipolar depression, with lower doses having less of an antidepressant effect and higher doses causing more dissociative side effects [8].”
BackgroundInfluential
Neurobiological Mechanisms of Ketamine: Depression, Suicide, Trauma, and Chronic Stress Pathologies
Averill, L. A., Averill, C. L., & Abdallah, C. G. (2020) · Psychiatric Annals · doi:10.3928/00485713-20200109-02 · Cited by 6
Efficacy and Tolerability of Two Novel “Standard of Care” Treatments—Intranasal Esketamine Versus Intravenous Ketamine—for Treatment-Resistant Depression in Naturalistic Clinical Practice: Protocol for a Pilot Observational Study
Gutiérrez, G., Rosenblat, J. D., Hawken, E. R., Swainson, J., & Vázquez, G. H. (2022) · JMIR Research Protocols · doi:10.2196/34711 · Cited by 7
Depression and Anxiety Disorders
Karamustafalıoğlu, O., & Yumrukçal, H. (2025) · Wiley eBooks · doi:10.1002/9781119870203.mpg003.pub2 · Cited by 8
Efficacy of racemic ketamine or esketamine monotherapy for reducing suicidal ideation in uni- or bipolar depression: a systematic review and meta-analysis
Li, J., Ma, L., Sun, H., Li, M., Cao, Y., Peng, Y., & Xu, J. (2025) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-024-01920-x · Cited by 5
“Another study comparing the efficacy and safety of four different doses of racemic ketamine with midazolam found no anti-SI benefit at the different doses of racemic ketamine compared with midazolam [ 64].”
Ketamine and chronic treatment-resistant depression: real-world practice and after relapse
Jobnah, S., Latifeh, Y., Kabani, D. A., & Youssef, L. A. (2024) · BMC Psychiatry · doi:10.1186/s12888-024-06203-2 · Cited by 8
“Ketamine is a general dissociative anesthetic that has shown a rapid antidepressant effect after a few hours of a single infusion among patients with TRD [11–14].”
Background
Glutamate plus glutamine to GABA ratio as a predictor of ketamine response in treatment-resistant depression: A double-blind, randomized, open-label extension study
Ohtani, Y., Tani, H., Honda, S., Nomoto‐Takahashi, K., Yatomi, T., Yonezawa, K., Tomiyama, S., Nagai, N., Kusudo, K., Moriyama, S., et al. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.04.165 · Cited by 5
Acute and long‐term effects of repeated ketamine infusions in treatment‐resistant depression and associated metabolite changes
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Li, M., Duan, W., Hao, X., Li, S., Wang, C., Liang, Y., Hu, Z., Ma, D., Guo, M., Zuo, C., et al. (2025) · Molecular Psychiatry · doi:10.1038/s41380-025-03198-4 · Cited by 5
“Over the past decade, the dissociative anesthetic ketamine has gained signi ﬁ cant attention for its rapid and sustained antidepressant effects in TRD patients [1, 2], although its precise pharmacological mechanisms remain unclear [3].”
Bifunctional Modulation of NMDA and Opioid Receptors in Ketamine Reinforcement and Misuse: Implications for Substance Use Disorder Treatment
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Self-citation
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“Due to its pharmacokinetic characteristic, ketamine can be administered in several ways in TRD, including intravenous (IV; e.g., [8]), intramuscular (IM; e.g., [9]), intranasal (IN; e.g., [10]), sublingual (e.g., [11]), subcutaneous (SC; e.g., [12]), and oral (e.g., [13]).”
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Kwaśna, J., Cubała, W. J., Kwaśny, A., & Wilkowska, A. (2024) · Pharmacological Reports · doi:10.1007/s43440-024-00637-x · Cited by 5
“This indicates an unmet need for an optimal ketamine dosing regimen [13].”
Influential
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Purposeful Drug Repurposing
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Self-citation
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Intravenous Ketamine as an Effective and Safe Treatment in a Suicidal Patient With Cancer Who Was Nil Per Os
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Unmet Needs in Psychiatry: Bipolar Depression
Baldessarini, R. J., Tondo, L., & Vázquez, G. H. (2020) · Springer eBooks · doi:10.1007/978-3-030-42637-8_4 · Cited by 5
A Case of Intranasal Ketamine Misuse: Considerations for Clinical Practice
Rivas-Grajales, A. M., Mathew, S. J., & Rodgers, J. J. (2021) · Journal of Psychiatric Practice · doi:10.1097/pra.0000000000000589 · Cited by 5
Self-citation
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Findeis, H., Ludwig, V. M., Mikoláš, P., Graff, J., Bauer, M., & Ritter, P. S. (2022) · Der Nervenarzt · doi:10.1007/s00115-021-01260-4 · Cited by 5
Clinical use of ketamine in psychiatric disorders
Dehestani, S., Mohammadpour, A. H., Sadjadi, S. A., Sathyapalan, T., & Sahebkar, A. (2022) · Annales Médico-psychologiques revue psychiatrique · doi:10.1016/j.amp.2022.05.008 · Cited by 6
Major depressive disorder (mdd): emerging immune targets at preclinical level
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Infusing Hope Into the Treatment of Suicidality: a Review of Ketamine’s Effects on Suicidality
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The dynamics of AMPA receptors underlies the efficacy of ketamine in treatment resistant patients with depression
Nakajima, W., Hatano, M., Ohtani, Y., Tani, H., Yatomi, T., Tsuchimoto, S., Fujimoto, Y., Eiro, T., Ichijo, S., Nakano, K., et al. (2026) · Molecular Psychiatry · doi:10.1038/s41380-026-03510-w · Cited by 4
Interdisciplinary, Delphi-driven consensus guidelines on the use of intravenous ketamine infusions for depressive disorders from the American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP3)
Mathai, D. S., Cluck, M., Aslam, A. M., Amato, E., Azam, A., Banov, M., Barrett, K. A., Bonnett, C. J., Feifel, D., Grundmann, N., et al. (2026) · Journal of Affective Disorders · doi:10.1016/j.jad.2026.121970 · Cited by 6
Long-Term Effects of Single and Repeated Ketamine Infusions on Treatment-Resistant Depression: A Retrospective Chart Review Study
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“…single ketamine infusion in TRD, the authors found that the standard low dose (0.5 mg/kg) and high dose (1 mg/kg) were superior to the active placebo, suggesting that both low-dose (0.5 mg/kg) and high-dose (1 mg/kg) ketamine are clinically effective in the reduction in depressive symptoms [31].”
Influential
Clinical trials since 2020 of rapid anti-suicidal ideation effects of ketamine and its enantiomers: a systematic review
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A randomized, double-blind, placebo-controlled, Phase 1 study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an immediate-release oral ketamine capsule in healthy volunteers
Qureshi, M. M., Silman, D., Gadelrab, R., Stein, H., Carmellini, P., Duncan, G., Mehta, M. A., Young, A. H., Reilly, C., & Juruena, M. F. (2025) · Journal of Psychopharmacology · doi:10.1177/02698811251340925 · Cited by 4
Use of Staging Models for Treatment-Resistant Depression Is Not Helpful in Predicting Nonresponse to Acute Intravenous Ketamine Treatment
Sakurai, H., Hoeppner, B., Jain, F., Foster, S., Pedrelli, P., Mischoulon, D., D, M. F. M., & Cusin, C. (2022) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000001524 · Cited by 4
Self-citation

Authors: Fava, M., Freeman, M. P., Flynn, M., Judge, H., Hoeppner, B. B., Cusin, C., Ionescu, D. F., Mathew, S. J., Chang, L. C., Iosifescu, D. V., Murrough, J., Debattista, C., Schatzberg, A. F., Trivedi, M. H., Jha, M. K., Sanacora, G., Wilkinson, S. T., & Papakostas, G. I.
Affiliations: Massachusetts General Hospital (US)
Michael E. DeBakey VA Medical Center (US)
Icahn School of Medicine at Mount Sinai (US)
Stanford Medicine (US)
The University of Texas Southwestern Medical Center (US)
Yale University (US)
ORCID: Freeman, Marlene P.
Hoeppner, Bettina B.
Cusin, Cristina
Mathew, Sanjay J.
Chang, Lee C.
Iosifescu, Dan V.
Murrough, James
Debattista, Charles
Schatzberg, Alan F.
Trivedi, Madhukar H.
Jha, Manish K
Sanacora, Gerard
Wilkinson, Samuel T.
Papakostas, George I.
Venue: Molecular Psychiatry
Publisher: Springer Science and Business Media LLC
Published: 2018-10-03
Volume: 25
Issue: 7
Pages: 1592-1603
ISSN: 1359-4184 (ISSN-L)
1476-5578
DOI: 10.1038/s41380-018-0256-5
PMC: PMC6447473
OpenAlex: W2895197076
Cited by: 433
References: 35
Citations by year: 2026: 28 · 2025: 69 · 2024: 79 · 2023: 54 · 2022: 54 · 2021: 59 · 2020: 60 · 2019: 28 · 2018: 1
FWCI: 23.88
Type: journal article
Language: en
Update notices: correction (2019-01-07)
Open access: bronze
doi.org
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
Locations: Molecular Psychiatry (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: U.S. Department of Health & Human Services | NIH | National Institute of Mental Health (HHSN271201100006I)
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: treatment-resistant depression, intravenous ketamine, rapid-acting antidepressants, dose-response relationship, NMDA receptor antagonists, active placebo, antidepressant efficacy, depression severity, outpatients, antidepressant safety, CGI-S, CGI-I, adjunctive therapy, suicidal ideation
MeSH terms: Adult, Antidepressive Agents, Depression, Double-Blind Method, Female, Humans, Infusions, Intravenous, Ketamine, Male, Middle Aged, Treatment Outcome, Depressive Disorder, Treatment-Resistant

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Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD)

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