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Published on: August 11, 2015
Intravenous arketamine for treatment-resistant depression: open-label pilot study
Gustavo C Leal1,2,3, Igor D Bandeira2,3, Fernanda S Correia-Melo2,3
1Hospital Universitário Professor Edgard Santos, Serviço de Psiquiatria, Universidade Federal da Bahia, 3º andar, Rua Dr. Augusto Viana S/N, Salvador, Bahia, 40110-060, Brazil.
Arketamine, a ketamine enantiomer, shows promising antidepressant effects for treatment-resistant depression (TRD) with minimal dissociation. This pilot study suggests potential for rapid and sustained mood improvement with a favorable safety profile.
Area of Science:
- Neuroscience
- Psychiatry
- Pharmacology
Background:
- Treatment-resistant depression (TRD) poses a significant challenge in mental healthcare.
- Ketamine has demonstrated rapid antidepressant effects, but its psychotomimetic side effects are a concern.
Purpose of the Study:
- To evaluate the efficacy and safety of arketamine, the R(-)-enantiomer of ketamine, in patients with TRD.
- To assess the potential of arketamine as a novel therapeutic agent for depression.
Main Methods:
- An open-label pilot trial involving seven subjects diagnosed with TRD.
- Administration of a single intravenous infusion of arketamine at a dose of 0.5 mg/kg.
- Assessment of depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) 24 hours post-infusion.
Main Results:
- A significant reduction in mean MADRS scores from 30.7 at baseline to 10.4 at 24 hours post-infusion (mean difference of 20.3 points; p < 0.001).
- Dissociative side effects were reported as nearly absent.
- The treatment demonstrated a favorable safety profile.
Conclusions:
- Arketamine may offer rapid-onset and sustained antidepressant effects in humans with TRD.
- The R(-)-enantiomer of ketamine presents a potentially safer alternative to racemic ketamine for depression treatment.
- Further controlled clinical trials are warranted to confirm these preliminary findings and establish optimal treatment protocols.
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