Clinical TrialTreatment-Resistant Depression (TRD)Completed

Racemic Ketamine and Esketamine Infusion in Treatment-Resistant Depression: A Randomised Controlled Trial (Quarantini Lab, UFBA Brazil)

This unregistered trial (n=61) was a randomised, double-blind, non-inferiority trial of racemic ketamine or esketamine infusions for treatment-resistant depression in adults, which identified clinical predictors for symptom remission and response.

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Target Enrollment
Not specified
Study Type
interventional
Design
Randomized, double Blind

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study was a randomised, double-blind, active-controlled, non-inferiority trial involving 61 participants diagnosed with major depressive disorder meeting treatment-resistant criteria. Participants were randomly assigned to receive either a single subanesthetic dose of racemic ketamine (0.5 mg/kg) or esketamine (0.25 mg/kg) via intravenous infusion.

Researchers assessed depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) at 24 hours and 7 days post-infusion. The analysis found that a higher number of previous therapeutic failures and greater baseline illness severity were significant predictors of reduced remission and response rates.

Study Details

Locations

Brazil

Related Publications

PaywallindividualPrimary

Clinical predictors of depressive symptom remission and response after racemic ketamine and esketamine infusion in treatment-resistant depression

In a randomised, double‑blind trial of single subanaesthetic infusions of racemic ketamine or esketamine in 61 people with treatment‑resistant major depressive disorder, higher baseline illness severity and a greater number of prior treatment failures predicted poorer outcomes. Specifically, more treatment failures and greater severity were associated with lower odds of remission at 7 days and reduced likelihood of response at 24 hours.

Published
Journal
Human Psychopharmacology
Authors
Jesus‐Nunes, A. P., Leal, G. C., Correia‐Melo, F. S., Vieira, F., Mello, R. P., Caliman‐Fontes, A. T., Echegaray, M. V. F., Marback, R. F., Guerreiro‐Costa, L. N. F., Souza‐Marques, B., Santos‐Lima, C., Souza, L. S., Bandeira, I. D., Kapczinski, F., Lacerda, A. L. T., Quarantini, L. C.