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

Completed · Phase 2 · Has a placebo group

Conditions studied: Treatment-Resistant Depression

In brief

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)

Key facts

Study ID

NCT05454410

Run by

Novartis Pharmaceuticals

People needed

60

Starts

2023-03-13

Expected to finish

2023-11-28

Last updated by the study team

2025-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent obtained prior to participation in the study
• Male and female participants, 18 to 65 years of age (inclusive) at screening
• DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
• MADRS score ≥ 24
• Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants

You may not qualify if…

• Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
• Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
• Participants with current borderline personality disorder or antisocial personality disorder
• Current clinical diagnosis of autism, dementia, or intellectual disability

Where it is running

• 25Uni of Alabama at Birmingham — Birmingham, Alabama, United States
• Research Centers of America LLC — Oakland Park, Florida, United States
• Interventional Psychiatry Tampa Bay — Tampa, Florida, United States
• Novartis Investigative Site — Yokohama, Kanagawa, Japan
• Novartis Investigative Site — Bialystok, Poland
• Novartis Investigative Site — Kodaira, Tokyo, Japan
• Novartis Investigative Site — Gdansk, Poland
• Novartis Investigative Site — Mitaka, Tokyo, Japan
• Novartis Investigative Site — Swiecie North West, Poland
• Novartis Investigative Site — Seville, Andalusia, Spain
• Novartis Investigative Site — Sabadell, Barcelona, Spain
• Novartis Investigative Site — Sant Boi de Llobregat, Barcelona, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Pamplona, Navarre, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Barcelona, Spain

Full record on ClinicalTrials.gov

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