For Healthcare Professionals

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


About the study

The main purpose of this study is 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)

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

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


Exclusion Criteria:

  1. Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
  2. 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.
  3. Participants with current borderline personality disorder or antisocial personality disorder
  4. Current clinical diagnosis of autism, dementia, or intellectual disability.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Treatment-Resistant Depression

Age (in years)

18 - 65


Phase 2

Participants needed


Est. Completion Date

Jan 5, 2024

Treatment type



Novartis identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.