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Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

NCT05454410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-13

Study results available
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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)

Conditions

  • Treatment-Resistant Depression

Interventions

DRUG

MIJ821 Subcutaneous Injection 1 mg

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

DRUG

MIJ821 Subcutaneous Injection 4 mg

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

DRUG

MIJ821 Subcutaneous Injection 10 mg

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

DRUG

Placebo Subcutaneous Injection

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2023-11-28
Completion
2023-11-28
FDA Drug
Yes

Countries

  • United States
  • Japan
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT05454410 on ClinicalTrials.gov