A multicentre, double-blind, randomised, placebo – controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subject with treatment-resistant depression in the course of Major Depressive Disorder

This multicentre, double-blind, randomised, placebo-controlled Phase II trial (n=88) assessed the efficacy, safety, and pharmacokinetics of inhaled esketamine in subjects with treatment-resistant depression (TRD) in the course of major depressive disorder.

Conducted by Celon Pharma SA in Poland, the trial aimed to determine Esketamine’s effectiveness, dose-response, and safety compared to a placebo. The primary outcome was measured by changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 14. Secondary objectives included evaluating the effect, durability, safety, and pharmacokinetic properties of Esketamine.

Exploratory objectives focused on genetic and biomarker correlations. The trial, part of a paediatric investigation plan, was authorised by the competent authority on August 29, 2018, and completed on April 24, 2020. The trial involved adult subjects, both male and female and had multiple sites across Poland.

Topic Treatment-Resistant Depression Depression
Compound Ketamine Placebo
Country Poland
Visit trial
Status Completed
Results Published No
Start date 28 June 2018
End date 24 April 2020
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 88
Sex All
Age 18- 65
Therapy No

Trial Details

The planned study is to determined the Esketamine’s efficacy (it's effectiveness and dose response) and pharmacokinetic properties (the fate of a substance in the body based on its concentration in the blood) and safety assessments (the occurrence of possible side effects) after multiple dose of inhaled Esketamine, compared to placebo in subject with treatment resistant depression in the course of major depressive disorder.

NCT Number 02KET2018

Data attribution

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