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Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression

Depressive Disorder, Treatment-Resistant Clinical Trial

Official title:
A Multi-center, Randomized, subject-and Investigator Blinded, Placebo-controlled, Active Comparator, Parallel-group Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Patients With Treatment-resistant Depression

Clinical Trial Summary

This study will evaluate the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study will be conducted in the US and in Europe (Spain and Czech Republic). The MIJ821 will be administered via infusion on a weekly or bi-weekly basis. The efficacy will be measured after 24 hours using a specific golden standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration is 6 weeks of treatment plus 1 month of follow up period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03756129
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email Novartis.email@novartis.com
Status Not yet recruiting
Phase Phase 2
Start date February 8, 2019
Completion date March 10, 2020
View Details
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