Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent

NCT ID: NCT04722666

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2023-09-26

Brief Summary

Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent

Detailed Description

The main purpose of this study is to support the dose selection for future Phase III clinical trials by evaluating efficacy and safety of four MIJ821 doses (very low, low, high and very high) administered every other week by intravenous infusion on top of pharmacological antidepressant treatment, compared with placebo, for the rapid reduction of the symptoms of MDD in participants who have suicidal ideation with intent. In addition, the study will explore the effect of single dose administration of very high and high doses to treat MDD in participants who have suicidal ideation with intent.

The study consists of three periods: a Screening Period (up to 48 hrs), a double-blind Core Period (6 weeks) and Extension Period (up to 52 weeks). The Extension Period will explore durability of the effect of the study treatment and the effect of MIJ821 on relapse rate, as well as safety of repeated MIJ821 administration.

All patients in the extension period will receive active treatment.

Conditions

Major Depressive Disorder With Suicidal Ideation With Intent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MIJ821 (mg/kg) - very low dose

MIJ821 (mg/kg) very low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Group Type: EXPERIMENTAL

MIJ821 Intravenous Injection

Intervention Type: DRUG

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

MIJ821 (mg/kg) - low dose

MIJ821 (mg/kg) low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Group Type: EXPERIMENTAL

MIJ821 Intravenous Injection

Intervention Type: DRUG

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

MIJ821(mg/kg) - high dose

MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Group Type: EXPERIMENTAL

MIJ821 Intravenous Injection

Intervention Type: DRUG

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

MIJ821 (mg/kg) - very high dose

MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Group Type: EXPERIMENTAL

MIJ821 Intravenous Injection

Intervention Type: DRUG

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Placebo

40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29

Group Type: PLACEBO_COMPARATOR

Placebo Intravenous Injection

Intervention Type: DRUG

40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

MIJ821 (mg/kg) - high dose/Placebo

MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1/0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29

Group Type: EXPERIMENTAL

MIJ821 Intravenous Injection

Intervention Type: DRUG

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Placebo Intravenous Injection

Intervention Type: DRUG

40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

MIJ821 (mg/kg) - very high dose/Placebo

MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1/0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29

Group Type: EXPERIMENTAL

MIJ821 Intravenous Injection

Intervention Type: DRUG

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Placebo Intravenous Injection

Intervention Type: DRUG

40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

Interventions

MIJ821 Intravenous Injection

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

Intervention Type: DRUG

Placebo Intravenous Injection

40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study

2. Male and female participants, 18 to 65 years of age (inclusive) at screening

3. DSM-5 defined major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features at the time of screening based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) assessed at Screening

4. Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 AND either Question B10 or Question B11 obtained from the M.I.N.I., assessed at Screening

5. Current suicidal ideation with intent, confirmed by "Yes" response to Question 3 AND either Question 9 or Question 10 obtained from the SSTS at Baseline

6. Montgomery-Åsberg Depression Rating Scale (MADRS) score > 28 at Screening and before randomization on Day 1

7. Participants must agree to receive pharmacological standard of care treatment to treat their MDD (as determined by the treating physician(s) based on clinical judgement and local treatment guidelines) during the trial duration

8. In the physician's opinion, acute psychiatric hospitalization is clinically warranted to treat the patient's condition, and the patient is either already in the hospital or agrees to be hospitalized voluntarily for the required per protocol period

Exclusion Criteria

1. Any prior or current diagnosis of bipolar disorder, MDD with psychotic features, schizophrenia, or schizoaffective disorder as obtained from M.I.N.I. at Screening

2. Patients with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or patients who went through detoxification treatment (inpatient or outpatient) within 1 month before Screening.

3. Participant has a current clinical diagnosis of autism, dementia, or intellectual disability

4. History of seizures. Note: childhood febrile seizures are not exclusionary

5. Participants with borderline personality disorder as obtained from M.I.N.I. at Screening.

6. Participants with suicidal ideation or behavior caused primarily by another non-MDD condition as obtained from M.I.N.I. at Screening

7. Participants taking medications prohibited by the protocol

8. Intake of the following medications/ psychotherapy:

1. Esketamine or Ketamine 2 months before Screening

2. Monoamine oxidase inhibitors (MAOIs) 14 days before Screening

3. Non-stable psychotherapy regimen and/or started less than 6 weeks before Screening

9. Any other condition (e.g. known liver disease/liver dysfunction, active malignancy, etc.) which in the opinion of the investigator would put the safety of the participant at risk, impede compliance or hinder completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Farmington, Connecticut, United States

Novartis Investigative Site

Oakland Park, Florida, United States

Novartis Investigative Site

Atlanta, Georgia, United States

Novartis Investigative Site

Rockville, Maryland, United States

Novartis Investigative Site

DeSoto, Texas, United States

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Novartis Investigative Site

São Bernardo do Campo, São Paulo, Brazil

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Toyoake, Aichi-ken, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Kodaira, Tokyo, Japan

Novartis Investigative Site

Seremban, Negeri Sembilan, Malaysia

Novartis Investigative Site

Kuala Lumpur, , Malaysia

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Novartis Investigative Site

Mazatlán, Sinaloa, Mexico

Novartis Investigative Site

San Luis Potosí City, , Mexico

Novartis Investigative Site

Groningen, , Netherlands

Novartis Investigative Site

Pruszków, Masovian Voivodeship, Poland

Novartis Investigative Site

Bialystok, , Poland

Novartis Investigative Site

Gdansk, , Poland

Novartis Investigative Site

Swiecie n/W, , Poland

Novartis Investigative Site

Lodz, Łódź Voivodeship, Poland

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, Spain

Novartis Investigative Site

Vitoria-Gasteiz, Basque Country, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, , Spain

Novartis Investigative Site

Barcelona, , Spain

Novartis Investigative Site

Taipei, , Taiwan

Novartis Investigative Site

Taipei, , Taiwan

Novartis Investigative Site

Bursa, Gorukle, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, TUR, Turkey (Türkiye)

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Countries

United States; Argentina; Brazil; Canada; Germany; Japan; Malaysia; Mexico; Netherlands; Poland; Russia; Spain; Taiwan; Turkey (Türkiye)

Other Identifiers

CMIJ821A12201

Identifier Type: -

Identifier Source: org_study_id