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
Inclusion Criteria:
- Signed informed consent must be 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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.
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
Contition
Treatment-Resistant Depression
Age (in years)
18 - 65
Phase
Phase 2
Participants needed
56
Est. Completion Date
Jan 5, 2024
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT05454410
Study number
CMIJ821B12201
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