Ketamine and other NMDA antagonists: early clinical trials and possible mechanisms in depression.

Newport, D. Jeffrey; Carpenter, Linda L.; McDonald, William M.; Potash, James B.; Tohen, Mauricio; Nemeroff, Charles B.; The APA Council of Research Task Force on Novel Biomarkers and Treatments

doi:10.1176/appi.ajp.2015.15040465

Cited by 599Treatment of Major DepressionElectroconvulsive Therapy StudiesTranscranial Magnetic Stimulation Studies

Ketamine and other NMDA antagonists: early clinical trials and possible mechanisms in depression.

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Newport, D. Jeffrey, Carpenter, Linda L., McDonald, William M., Potash, James B., Tohen, Mauricio, Nemeroff, Charles B., The APA Council of Research Task Force on Novel Biomarkers and Treatments·2015·American Journal of Psychiatry

DOI 10.1176/appi.ajp.2015.15040465

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Abstract

OBJECTIVE: The authors conducted a systematic review and meta-analysis of ketamine and other N-methyl-d-aspartate (NMDA) receptor antagonists in the treatment of major depression. METHOD: Searches of MEDLINE, PsycINFO, and other databases were conducted for placebo-controlled, double-blind, randomized clinical trials of NMDA antagonists in the treatment of depression. Primary outcomes were rates of treatment response and transient remission of symptoms. Secondary outcomes included change in depression symptom severity and the frequency and severity of dissociative and psychotomimetic effects. Results for each NMDA antagonist were combined in meta-analyses, reporting odds ratios for dichotomous outcomes and standardized mean differences for continuous outcomes. RESULTS: Ketamine (seven trials encompassing 147 ketamine-treated participants) produced a rapid, yet transient, antidepressant effect, with odds ratios for response and transient remission of symptoms at 24 hours equaling 9.87 (4.37-22.29) and 14.47 (2.67-78.49), respectively, accompanied by brief psychotomimetic and dissociative effects. Ketamine augmentation of ECT (five trials encompassing 89 ketamine-treated participants) significantly reduced depressive symptoms following an initial treatment (Hedges' g=0.933) but not at the conclusion of the ECT course. Other NMDA antagonists failed to consistently demonstrate efficacy; however, two partial agonists at the NMDA coagonist site, d-cycloserine and rapastinel, significantly reduced depressive symptoms without psychotomimetic or dissociative effects. CONCLUSIONS: The antidepressant efficacy of ketamine, and perhaps D-cycloserine and rapastinel, holds promise for future glutamate-modulating strategies; however, the ineffectiveness of other NMDA antagonists suggests that any forthcoming advances will depend on improving our understanding of ketamine's mechanism of action. The fleeting nature of ketamine's therapeutic benefit, coupled with its potential for abuse and neurotoxicity, suggest that its use in the clinical setting warrants caution.

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Rapastinel has been studied in 3 clinical trials to date with relatively weak evidence for its efficacy.
“Of note, however, rapastinel, another drug that reverses synaptic plasticity deficits and exhibits antidepressant-like effects in rodent models 36,37 , has been studied in 3 clinical trials to date with relatively weak evidence for its efficacy 38 .”
From Neuroplasticity in cognitive and psychological mechanisms of depression: an integrative model (2020) · cites this paper as [38]
The Rapastinel (GLYX-13) Study section identifies one randomized clinical trial, and the Discussion lists other agents—but not rapastinel—as having more than one published clinical trial. The Efficacy section supports a cautious assessment of efficacy: response and remission rates did not differ significantly from placebo, although some doses improved depression scores. (LLM, conf=0.87)
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Ketamine exhibits rapid onset and robust short-term antidepressant effect in patients with treatment-resistant depression.
“Ketamine, an antagonist of the glutamatergic N-methyl-D-aspartate (NMDA) receptor (an ionotropic glutamate receptor), was shown to exhibit rapid onset and robust, short-term antidepressant effect in patients with treatment-resistant depression (TRD) [1–3].”
From Cardiac Safety of Esketamine Nasal Spray in Treatment-Resistant Depression: Results from the Clinical Development Program (2020) · cites this paper as [1]
Ketamine at a dose of 0.5mg/kg has consistently been shown to have robust and rapid antidepressant effects.
“Racemic ketamine was obtained from the Yale-New Haven Hospital Pharmacy and administered intravenously by constant infusion over 40 minutes at a dose of 0.5mg/kg, which has consistently been shown to have robust and rapid antidepressant effects 7,8 , and is typically used clinically.”
From Imaging the effect of ketamine on synaptic density (SV2A) in the living brain (2022) · cites this paper as [8]
Other NMDA receptor antagonists such as memantine, lanicemine and nitrous oxide do not exert a consistent antidepressant effect in RCTs.
“This is supported by the finding that other NMDA receptor antagonists such as memantine, lanicemine and nitrous oxide do not exert a consistent antidepressant effect in RCTs.90”
From Ketamine as an antidepressant: Overview of its mechanisms of action and potential predictive biomarkers (2020) · cites this paper as [90]
Ketamine's antidepressant effects versus placebo are supported by several meta-analyses.
“Ketamine's antidepressant effects compared to placebo controls are further supported by several thorough meta-analyses [134-136].”
From Plasticity of synapses and reward circuit function in the genesis and treatment of depression (2023) · cites this paper as [134]

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Untitled work
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Untitled work
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Authors: Newport, D. J., Carpenter, L. L., McDonald, W. M., Potash, J. B., Tohen, M., Nemeroff, C. B., & The APA Council of Research Task Force on Novel Biomarkers and Treatments
Affiliations: University of Miami (US)
University of Iowa (US)
ORCID: Newport, D. Jeffrey
Carpenter, Linda L.
McDonald, William M.
Potash, James B.
Tohen, Mauricio
Nemeroff, Charles B.
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2015-10-01
Volume: 172
Issue: 10
Pages: 950-966
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/appi.ajp.2015.15040465
OpenAlex: W2111728433
Semantic Scholar: 1554f1974f06fcabaaf6be07d58e1ebf23572172
Cited by: 598
References: 177
Citations by year: 2026: 27 · 2025: 36 · 2024: 37 · 2023: 50 · 2022: 53 · 2021: 65 · 2020: 62 · 2019: 65 · 2018: 71 · 2017: 64 · 2016: 62 · 2015: 5
FWCI: 8.46
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Funders: American Foundation for Suicide Prevention
Bristol-Myers Squibb
Eli Lilly and Company
Pfizer
AstraZeneca
GlaxoSmithKline
Teva Pharmaceutical Industries
Brown University
Celgene
University of Miami
Emory University
Sunovion
National Alliance for Research on Schizophrenia and Depression
OPKO Health
University of Oxford
Mitsubishi Tanabe Pharma Corporation
H. Lundbeck A/S
National Institutes of Health
Health Resources and Services Administration
School of Medicine, Emory University
Allergan
Leonard M. Miller School of Medicine
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
National Institute of Mental Health
Topics: Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
Keywords: ketamine, NMDA receptor antagonists, major depressive disorder, antidepressant efficacy, rapid-acting antidepressants, D-cycloserine, psychotomimetic effects, dissociative effects, glutamate modulation, treatment response, remission
MeSH terms: Antidepressive Agents, Depressive Disorder, Major, Major Depressive Disorder, Humans, Ketamine, Receptors, N-Methyl-D-Aspartate, Excitatory Amino Acid Antagonists

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Ketamine and other NMDA antagonists: early clinical trials and possible mechanisms in depression.

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