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
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.
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