CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
MIJ821 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03756129
NCT03756129Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Nov 28, 2018·Updated Oct 8, 2021

In Brief

A Phase 2 clinical trial evaluating MIJ821, Placebo, and 1 other intervention for Depressive Disorder, Treatment-Resistant. Completed, enrolled 70 participants across 12 sites in 2 countries.

Detailed Summary

This study evaluated 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 was conducted in the US and in Europe (Spain). The MIJ821 was administered via infusion on a weekly or bi-weekly basis. The efficacy was measured after 24 hours using a specific golden standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration was 6 weeks of treatment plus 1 month of follow up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Treatment-Resistant
CountriesSpain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 28, 2018
Enrollment StartFeb 8, 2019
Primary CompletionMar 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.6 years ago

Interventions

MIJ821drug

Different dosages and different regimen for MIJ821

Placebodrug

Infusion

Ketaminedrug

Infusion