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

NCT03965871 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-03-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Center for Research and Development, Poland

    collaborator OTHER

  • Celon Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2021-01-03
Completion
2021-02-19

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03965871 on ClinicalTrials.gov