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

• Status: Not yet recruiting
• Trial end date: 2023-09-13
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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:

• 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.