CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
MIJ821 Subcutaneous Injection 1 mg +3 moredrug
Likely dose
MIJ821 Subcutaneous Injection 1 mgfrom 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/NCT05454410
NCT05454410Phase 2Completed

A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression

Novartis Pharmaceuticals·interventional·Posted Jul 12, 2022·Updated Apr 13, 2025

In Brief

A Phase 2 clinical trial evaluating MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg, and 2 other interventions for Treatment-Resistant Depression. Completed, enrolled 60 participants across 16 sites in 4 countries.

Detailed Summary

The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant depression (TRD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJul 12, 2022
Enrollment StartMar 13, 2023
Primary CompletionNov 28, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.0 years ago

Interventions

MIJ821 Subcutaneous Injection 1 mgdrug

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 Subcutaneous Injection 4 mgdrug

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 Subcutaneous Injection 10 mgdrug

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

Placebo Subcutaneous Injectiondrug

0.9% sodium chloride solution administered as a single SC injection on Day 1.