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

NCT ID: NCT05454410

Last Updated: 2025-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2023-11-28

Brief Summary

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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)

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Detailed Description

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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).

Conditions

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Treatment-Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MIJ821 1 mg

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

Group Type EXPERIMENTAL

MIJ821 Subcutaneous Injection 1 mg

Intervention Type DRUG

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 4 mg

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

Group Type EXPERIMENTAL

MIJ821 Subcutaneous Injection 4 mg

Intervention Type DRUG

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 10 mg

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

Group Type EXPERIMENTAL

MIJ821 Subcutaneous Injection 10 mg

Intervention Type DRUG

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Subcutaneous Injection

Intervention Type DRUG

0.9% sodium chloride solution administered as a single SC injection on Day 1.

Interventions

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MIJ821 Subcutaneous Injection 1 mg

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

Intervention Type DRUG

MIJ821 Subcutaneous Injection 4 mg

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

Intervention Type DRUG

MIJ821 Subcutaneous Injection 10 mg

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

Intervention Type DRUG

Placebo Subcutaneous Injection

0.9% sodium chloride solution administered as a single SC injection on Day 1.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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25Uni of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Research Centers of America LLC

Oakland Park, Florida, United States

Site Status

Interventional Psychiatry Tampa Bay

Tampa, Florida, United States

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kodaira, Tokyo, Japan

Site Status

Novartis Investigative Site

Mitaka, Tokyo, Japan

Site Status

Novartis Investigative Site

Bialystok, , Poland

Site Status

Novartis Investigative Site

Gdansk, , Poland

Site Status

Novartis Investigative Site

Swiecie North West, , Poland

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Sabadell, Barcelona, Spain

Site Status

Novartis Investigative Site

Sant Boi de Llobregat, Barcelona, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Pamplona, Navarre, Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Countries

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United States Japan Poland Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2420

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

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2021-005992-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMIJ821B12201

Identifier Type: -

Identifier Source: org_study_id

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