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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.