Clinical TrialKetamineCompleted

Intravenous Arketamine for Treatment-Resistant Depression: Open-Label Pilot Study (UMIN000038347, Federal University of Bahia, Brazil)

Open-label pilot trial (UMIN000038347; Correia-Melo FS et al.; Federal University of Bahia / University Hospital, Salvador, Brazil; Eur Arch Psychiatry Clin Neurosci 2020, DOI 10.1007/s00406-020-01110-5). Participants: 7 adults (ages 18–65) with DSM-5 MDD, MADRS ≥25, failure to respond to ≥2 adequate antidepressant trials in current episode. No control arm, no randomisation. Intervention: single IV infusion of arketamine (R-ketamine, >99.0% enantiomeric purity, R/S ratio >99.5:0.5) at 0.5 mg/kg over 40 minutes; concomitant antidepressants continued. Primary outcome: MADRS change from baseline to 24 hours post-infusion. Results: mean MADRS dropped from 30.7 to 10.4 (mean difference 20.3 points; 95% CI 13.6–27.0; p<0.001); dissociation near-absent. Registry: UMIN (WHO ICTRP-listed Japanese registry).

Target Enrollment
7 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Arketamine

experimental

Single intravenous infusion of arketamine (R-ketamine)

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    delivered over 40 min

Primary Results(1 publication)

Participants

N = 7C. et al. 2020 →

MADRS

Score at Timepoint

Arketamine10.4Day 1·C. et al. 2020 →

Response Rates

≥50% reduction in baseline MADRS

7/7(100.0%)·C. et al. 2020 →
5/7(71.4%)·C. et al. 2020 →
4/7(57.1%)·C. et al. 2020 →

MADRS < 10 (remission)

6/7(85.7%)·C. et al. 2020 →
4/7(57.1%)·C. et al. 2020 →
3/7(42.9%)·C. et al. 2020 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Arketamineexperimental7——0(0.0%)—

* The paper reports specific mild/transient side effects: blurred vision (3 subjects) and dizziness (2 subjects). No serious adverse events were reported.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment7 participants
  • Timeline
    Start: 2019-01-01
    End: 2020-01-01
  • Compound
    Ketamine

Related Publications

Intravenous arketamine for treatment-resistant depression: open-label pilot study

Published
Authors
Leal, G. C., Bandeira, I. D., Correia-Melo, F. S., Telles, M., Mello, R. P., Vieira, F., Lima, C. S., Paula, A., Guerreiro-Costa, L. N. F., Marback, R. F., Caliman-Fontes, A. T., Marques, B. L. S., Bezerra, M. L. O., Dias-Neto, A. L., Silva, S. S., Sampaio, A. S., Sanacora, G., Turecki, G., Loo, C., Lacerda, A. L. T., Quarantini, L. C., Hashimoto, K.

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