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Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent

NCT04722666 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2026-05-18

Study results available
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Summary

Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent

Conditions

  • Major Depressive Disorder With Suicidal Ideation With Intent

Interventions

DRUG

MIJ821 Intravenous Injection

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

DRUG

Placebo Intravenous Injection

40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2023-09-26
Completion
2023-09-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Germany
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Taiwan
  • Turkey (Türkiye)

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 NCT04722666 on ClinicalTrials.gov