A multicentre, double-blind, randomised, placebo – controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subjects with treatment-resistant bipolar depression

This double-blind, randomised, placebo-controlled Phase II trial (n=88) was conducted in Poland by Celon Pharma SA The study aimed to assess the efficacy, safety, and pharmacokinetics of inhaled Esketamine in subjects aged 18-65 with treatment-resistant bipolar depression.

The primary objective was to determine esketamine’s effectiveness and dose response, evaluated by the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 14. Secondary objectives included assessing clinical response, time to relapse, safety, tolerability, and pharmacokinetic properties.

The trial, completed on February 19, 2021, had a duration of 12 months and involved 13 sites in Poland. The Competent Authority authorised the trial on September 10, 2018, and the Ethics Committee provided a favourable opinion on September 18, 2018.

Code 03KET2018.

Topic Treatment-Resistant Depression Depression
Compound Ketamine Placebo
Country Poland
Visit trial
Status Completed
Results Published No
Start date 30 July 2018
End date 19 February 2021
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 88
Sex All
Age 18- 65
Therapy Yes

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 bipolar depression.

Trial Number 2018-002669-20

Data attribution

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