NCT03965871

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression

A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Celon Pharma SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.

Detailed description

This is a randomized, multiple dose, placebo-controlled, double-blind, multicentre study of Esketamine DPI, inhalation powder delivered via dry powder inhaler (DPI) in participants with TRBD. There are 3 study phases: Screening phase, a two weeks double-blind treatment phase and a 6-week follow-up phase. Participants are to be randomized in 1:1:1:1 ratio to receive placebo or one of the three doses of Esketamine DPI. Participants from each group will receive different dosing sequences, consider as a single dose, corresponding to low, medium, high Esketamine dose or placebo. Participants will undergo one cycle of treatment consisting of four doses of Esketamine DPI or placebo over 14-day period. Participants safety will be monitored throughout the study.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Esketamine DPI - low dose	Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose.
DRUG	Esketamine DPI - medium dose	Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose.
DRUG	Esketamine DPI - high dose	Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose.
DRUG	Placebo DPI	Placebo DPI is to be administered via dry powder inhaler.

Timeline

• Start date: 2019-03-28
• Primary completion: 2021-01-03
• Completion: 2021-02-19
• First posted: 2019-05-29
• Last updated: 2021-03-19

Locations

12 sites across 1 country: Poland