Evidence map›Paper›PMID 32523677›Full record

ArticleTherapeutic advances in psychopharmacology2020

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study.

Paul Glue, Natalie J Medlicott, Shona Neehoff, Peter Surman, Fred Lam, Noelyn Hung, Cheung-Tak Hung

Abstract read
In one paragraph

Article in Therapeutic advances in psychopharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Ketamine treatment for refractory anxiety: A systematic review.British journal of clinical pharmacology · 2022
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  9. Ketamine or Esketamine in Special Populations of Patients With Treatment-Resistant Depression.Medical science monitor : international medical journal of experimental and clinical research · 2026
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  19. Ketamine in neuropsychiatric disorders: an update.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Paul GlueHazel Buckland Chair of Psychological Medicine, School of Medical Sciences, University of Otago, PO Box 913, Dunedin, 9054, New Zealand.ORCID https://orcid.org/0000-0002-7305-2800
Natalie J MedlicottSchool of Pharmacy, University of Otago, Dunedin, New Zealand.
Shona NeehoffPsychological Medicine, University of Otago, Dunedin, New Zealand.
Peter SurmanDouglas Pharmaceuticals Ltd, Auckland, New Zealand.
Fred LamZenith Technology Ltd, Dunedin, New Zealand.
Noelyn HungZenith Technology Ltd, Dunedin, New Zealand.
Cheung-Tak HungZenith Technology Ltd, Dunedin, New Zealand.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKetamine's defining side effects are dissociation and increased blood pressure/heart rate. An oral formulation with delayed absorption could minimize these effects. We recently reported safety and tolerability data for an extended release ketamine tablet in healthy volunteers.

methodsTo assess safety, tolerability, efficacy, and pharmacokinetics of an extended release oral ketamine tablet in patients with treatment-resistant depression/anxiety. This was a multiple dose open-label flexible dose uncontrolled study in seven patients with treatment-resistant depression/anxiety, who had all previously demonstrated mood improvement to subcutaneous ketamine. Assessments included ratings of anxiety, depression and dissociation, safety and tolerability, and blood samples for ketamine pharmacokinetics and brain-derived neurotrophic factor (BDNF) concentrations.

resultsImprovements in anxiety and depression ratings occurred gradually over 96 h; all patients had >50% improvements in mood ratings. Ketamine was safe and well tolerated, with no changes in vital signs, and a single brief report of dissociation. Ketamine may induce its own metabolism, as the ratio of norketamine to ketamine increased out to 96 h. Serum BDNF concentrations did not change during the study.

conclusionKetamine's safety/tolerability may be improved with an extended release oral formulation. Onset of mood improvement is slightly delayed compared with parenteral dosing. These data support the further development of extended release ketamine tablets for treatment of resistant depression and anxiety disorders.

Indexed as

anxietydepressiondissociationextended-release ketamine tabletfirst-in-patientpharmacodynamicspharmacokineticssafety

Identifiers

PMID32523677
PMCPMC7235665

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.