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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression

ClinicalTrials.gov Identifier: NCT05454410

Novartis Reference Number: CMIJ821B12201

Last Update: Jan 09, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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)

Condition

Treatment-Resistant Depression

Phase

Phase 2

Overall status

Recruiting

Start date

Jan 31, 2023

Completion date

Sep 13, 2023

Gender

All

Age(s)

18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug

MIJ821 Subcutaneous Injection - low dose

MIJ821 supplied in vials as a powder for solution for injection, to be reconstituted, and administered as a single subcutaneous injection on Day 1

Drug

MIJ821 Subcutaneous Injection - medium dose

MIJ821 supplied in vials as a powder for solution for injection, to be reconstituted, and administered as a single subcutaneous injection on Day 1

Drug

MIJ821 Subcutaneous Injection - high dose

MIJ821 supplied in vials as a powder for solution for injection, to be reconstituted, and administered as a single subcutaneous injection on Day 1

Drug

Placebo Subcutaneous Injection

0.9% sodium chloride solution to be administered as a single subcutaneous injection on Day 1

Eligibility 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.