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

Novartis

Status and phase: Completed; Phase 2

Conditions: Treatment-Resistant Depression

Treatments: Drug: MIJ821 Subcutaneous Injection 10 mg; Drug: MIJ821 Subcutaneous Injection 1 mg; Drug: MIJ821 Subcutaneous Injection 4 mg; Drug: Placebo Subcutaneous Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05454410

2021-005992-38 (EudraCT Number)

CMIJ821B12201

Details and patient eligibility

About

The main purpose of this study was 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)

Full description

The trial included a screening period of up to 28 days. On Day 1, after screening, eligible participants were randomized to one of the treatment arms (1 mg, 4 mg, or 10 mg of MIJ821) or placebo and received study treatment administered as a single subcutaneous injection. Participants remained at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. Post-dose clinic visits occurred 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments included the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments included laboratory tests, ECGs, vital signs and physical examinations. In addition, phone calls were conducted 3 days after each on-site clinic visit with the exception of the End-of-study (EOS) visit. EOS visit was completed on site on Day 29. Including screening, participants were in the study for up to 8 weeks (57 days).

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

MIJ821 1 mg

Experimental group

Description:

Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.

Treatment:

Drug: MIJ821 Subcutaneous Injection 1 mg

MIJ821 4 mg

Experimental group

Description:

Participants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1.

Treatment:

Drug: MIJ821 Subcutaneous Injection 4 mg

MIJ821 10 mg

Experimental group

Description:

Participants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1.

Treatment:

Drug: MIJ821 Subcutaneous Injection 10 mg

Placebo

Placebo Comparator group

Description:

Participants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1.

Treatment:

Drug: Placebo Subcutaneous Injection