Intramuscular ketamine vs. escitalopram and aripiprazole in acute and maintenance treatment of patients with treatment-resistant depression: A randomized double-blind clinical trial
M. Cigognini, A. G. Guirado, Denise van de Meene, M. A. Schneider, Mônica Sarah Salomon, Vinicius Santana de Alexandria, Juliana Adriano, Ana Maria Thaler, Fernando Dos Santos Fernandes, A. Carneiro, R. Moreno
Frontiers in Psychiatry July 22, 2022 DOI: 10.3389/fpsyt.2022.830301 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Double-blind Peer reviewed |
|---|---|
| Population | Adults aged 18-40 with treatment-resistant depression of moderate to severe intensity, without psychotic symptoms, with or without suicide risk |
| Interventions | Ketamine escitalopram aripiprazole |
| Dose | ketamine 0.75 mg/kg; escitalopram 15 mg; aripiprazole 5 mg |
| Duration | 4 weeks acute treatment and 24 weeks maintenance treatment |
| Measures | Montgomery-Åsberg Depression Rating Scale (MADRS) |
| Topics | Depression Esketamine Ketamine |
| Registration | NCT04234776 |
| Key findings | The authors propose that repeated-dose intramuscular ketamine may provide an ultra-rapid, low-cost treatment for treatment-resistant depression associated with less patient discomfort and reduced use of medical resources, and that the trial can clarify long-term effects including neuropsychological outcomes. No efficacy results are reported; the study is described as ongoing. |
Abstract
Objective: Ketamine, an N-methyl D-aspartate (NMDA) receptor antagonist, can promote rapid action in the management of individuals with treatment-resistant depression (TRD) at sub-anesthetic doses. However, few studies have investigated the long-term use of ketamine administered intravenously (IV) and intranasally (IN). We report the design and rationale of a therapeutic trial for assessing the efficacy, safety, and tolerability of repeated-dose intramuscular (IM) ketamine vs. active treatment (escitalopram and aripiprazole) in TRD patients.
Methods: A comparative, parallel-group, randomized double-blind trial assessing the efficacy, safety, and tolerability of acute (4 weeks) and maintenance (24 weeks) use of IM ketamine (0.75 mg/kg) vs. active control (escitalopram 15 mg and aripiprazole 5 mg) in individuals with moderate-severe intensity TRD (no psychotic symptoms) with or without suicide risk will be conducted. Patients with TRD (18–40 years) will be randomized and blinded to receive ketamine IM or active treatment at a 1:1 ratio for 4 weeks (active treatment) and 24 weeks (maintenance treatment). Subjects will be assessed using clinical scales, monitored for vital signs (VS) after application of injectable medication, and undergo neuropsychological tests. The primary outcome will be changed on the Montgomery-Åsberg Depression Rating Scale (MADRS) during the course of the trial. The study is in running.
Results: This study can potentially yield evidence on the use of IM ketamine in the treatment of depressive disorders as an ultra-rapid low-cost therapy associated with less patient discomfort and reduced use of medical resources, and can elucidate long-term effects on different outcomes, such as neuropsychological aspects.
Conclusions: The trial can help promote the introduction of a novel accessible approach for the treatment of complex disease (TRD) and also allow refinement of its long-term use. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT04234776, identifier: NCT04234776.
Comparable studies
Other randomized controlled trials on ketamine for depression, most cited first.