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Efficacy and Safety of a Rapid Intravenous Injection of Ketamine 0.5 mg/kg in Treatment-Resistant Major Depression: An Open 4-Week Longitudinal Study.

Sonia Vidal, Marianne Gex-Fabry, Victor Bancila, Giorgio Michalopoulos, Delphine Warrot, Françoise Jermann, Alexandre Dayer, Virginie Sterpenich, Sophie Schwartz, Laszlo Vutskits, Nawaz Khan, Jean-Michel Aubry, Markus Kosel

Journal of Clinical Psychopharmacology December 2018 DOI: 10.1097/jcp.0000000000000960 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label, noncontrolled clinical trial Longitudinal Peer reviewed
Sample size 10
Population Outpatients with treatment-resistant depression
Intervention Ketamine
Dose 0.5 mg/kg
Duration 4-week study
Measures Montgomery-Åsberg Depression Rating Scale, Scale for Suicide Ideation
Topics Depression Esketamine Ketamine
Key findings A single rapid 1-minute intravenous injection of ketamine 0.5 mg/kg reduced depression severity from 40 minutes until day 15 and suicidal ideation until day 7 in 10 outpatients with treatment-resistant depression; 8 became responders within 1 day, but all were nonresponders by 4 weeks. The authors suggest the treatment was well tolerated and efficacious in acute management, and that larger studies are needed.

Abstract

Ketamine has been documented for its rapid antidepressant effects. However, optimal dose and delivery route have not yet been thoroughly investigated. The objectives of this study were to document the safety and test the antidepressant and antisuicidal effects of a single rapid 1-minute injection of ketamine 0.5 mg/kg in treatment-resistant depression (TRD). Ten patients with TRD were included in an open, noncontrolled 4-week study and received a rapid intravenous dose of ketamine 0.5 mg/kg. Main outcome measure was the Montgomery-Åsberg Depression Rating Scale and suicidality was assessed using the Scale for Suicide Ideation. Rapid injection of ketamine elicited transient increase of blood pressure and altered states of consciousness in all patients and mild psychotomimetic effects in 4 patients, which all resolved without any intervention. Decrease of depression severity was observed from 40-minute postinjection until day 15. Eight patients became responders within 1 day and all were nonresponders after 4 weeks. The decrease of suicidal ideation was significant until day 7. Analysis indicated that higher severity of depression and anxiety at baseline predicted a larger Montgomery-Åsberg Depression Rating Scale decrease after 4 weeks. This study suggests that in well-controlled medical settings with adequate monitoring, a single rapid 1-minute injection of ketamine 0.5 mg/kg can be well tolerated and is efficacious in rapidly reducing depression symptoms and suicidal thoughts in outpatients with TRD. These findings are relevant to the practice of general clinical psychiatry and emergency departments were ketamine can have a place in acute management of TRD. Larger studies are necessary to confirm these results.

Comparable studies

Other non-randomized and open-label trials on ketamine, most cited first.

Study Year Design Participants
Rapid Resolution of Suicidal Ideation After a Single Infusion of anN-Methyl-D-Aspartate Antagonist in Patients With Treatment-Resistant Major Depressive Disorder Subjects with DSM-IV-diagnosed treatment-resistant major depressive disorder 2010 Open-label trial n = 33
Intravenous arketamine for treatment-resistant depression: open-label pilot study Humans with treatment-resistant depression 2020 Open-label pilot trial n = 7
A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide. Hospitalized patients with Major Depressive Disorder and acute suicidal ideation and... 2024 Open label study n = 17
Ketamine Psychedelic Therapy (KPT): A Review of the Results of Ten Years of Research Alcoholic patients 1997 Controlled clinical trial n = 211
Ketamine Safety and Tolerability in Clinical Trials for Treatment-Resistant Depression Participants with DSM-IV-defined major depressive disorder and treatment-resistant... 2014 Pooled analysis of three clinical trials n = 97

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