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

NCT04722666 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: CMIJ821A12201
• Study Type: interventional
• Target: 200
• Locations: 14 countries
• Sites: 39

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

Conditions

Major Depressive Disorder With Suicidal Ideation With Intent

Keywords

Major Depressive Disorder; Mental disorder; Mood disorder; Depression; Suicide; Suicidal Ideation; Suicidal intent; Suicidal risk; Self-Injurious Behavior; MIJ821; Antidepressive Agent; Psychotropic Drug; Hospitalization; Intravenous; Placebo; Adult

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS)

  The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS will be collected electronically by qualified personnel

  Baseline (first infusion) at 24 hours and up to 52 weeks

Secondary Outcomes (8)

• Number and severity of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI)

  Baseline up to 6 weeks

• Pharmacokinetics (PK) of MIJ821 in plasma

  Baseline up to 52 weeks

• Percentage of participants meeting response criteria of ≥50% reduction

  Baseline up to 6 weeks

• Percentage of participants meeting criteria for sustained response of ≥50% reduction

  Baseline up to 6 weeks

• Percentage of participants meeting remission criteria of MADRS total score of ≤12

  Baseline up to 6 weeks

Study Arms (7)

MIJ821 (mg/kg) - very low dose

EXPERIMENTAL

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

Drug: MIJ821 Intravenous Injection

MIJ821 (mg/kg) - low dose

EXPERIMENTAL

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

Drug: MIJ821 Intravenous Injection

MIJ821(mg/kg) - high dose

EXPERIMENTAL

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

Drug: MIJ821 Intravenous Injection

MIJ821 (mg/kg) - very high dose

EXPERIMENTAL

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

Drug: MIJ821 Intravenous Injection

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Intravenous Injection

MIJ821 (mg/kg) - high dose/Placebo

EXPERIMENTAL

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

Drug: MIJ821 Intravenous Injection; Drug: Placebo Intravenous Injection

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

EXPERIMENTAL

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

Drug: MIJ821 Intravenous Injection; Drug: Placebo Intravenous Injection

Interventions

MIJ821 Intravenous Injection 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/Placebo; MIJ821 (mg/kg) - low dose; MIJ821 (mg/kg) - very high dose; MIJ821 (mg/kg) - very high dose/Placebo; MIJ821 (mg/kg) - very low dose; MIJ821(mg/kg) - high dose

Placebo Intravenous Injection 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) - very high dose/Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.
• Participant has a current clinical diagnosis of autism, dementia, or intellectual disability
• Participants with borderline personality disorder as obtained from M.I.N.I. at Screening.
• Participants with suicidal ideation or behavior caused primarily by another non-MDD condition as obtained from M.I.N.I. at Screening
• Participants taking medications prohibited by the protocol
• Intake of the following medications/ psychotherapy:
• Esketamine or Ketamine 2 months before Screening
• Monoamine oxidase inhibitors (MAOIs) 14 days before Screening
• Non-stable psychotherapy regimen and/or started less than 6 weeks before Screening
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (39)

Novartis Investigative Site

Birmingham, Alabama, 35294-3300, United States

Location

Novartis Investigative Site

Farmington, Connecticut, 06030-3100, United States

Location

Novartis Investigative Site

Oakland Park, Florida, 33334, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30331, United States

Location

Novartis Investigative Site

Rockville, Maryland, 20850, United States

Location

Novartis Investigative Site

DeSoto, Texas, 75115, United States

Location

Novartis Investigative Site

Buenos Aires, C1429DUC, Argentina

Location

Novartis Investigative Site

Fortaleza, Ceará, 60430-270, Brazil

Location

Novartis Investigative Site

São Bernardo do Campo, São Paulo, 09726-150, Brazil

Location

Novartis Investigative Site

Toronto, Ontario, M5B 1W8, Canada

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Toyoake, Aichi-ken, 470-1168, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Novartis Investigative Site

Kodaira, Tokyo, 187-8551, Japan

Location

Novartis Investigative Site

Seremban, Negeri Sembilan, 70300, Malaysia

Location

Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64460, Mexico

Location

Novartis Investigative Site

Mazatlán, Sinaloa, 82140, Mexico

Location

Novartis Investigative Site

San Luis Potosí City, 78213, Mexico

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Novartis Investigative Site

Pruszków, Masovian Voivodeship, 05-802, Poland

Location

Novartis Investigative Site

Bialystok, 15 276, Poland

Location

Novartis Investigative Site

Gdansk, 80 952, Poland

Location

Novartis Investigative Site

Swiecie n/W, 86-100, Poland

Location

Novartis Investigative Site

Lodz, Łódź Voivodeship, 91-229, Poland

Location

Novartis Investigative Site

Moscow, 107258, Russia

Location

Novartis Investigative Site

Moscow, 115419, Russia

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Novartis Investigative Site

Vitoria-Gasteiz, Basque Country, 01004, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, 08025, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Taipei, 10048, Taiwan

Location

Novartis Investigative Site

Taipei, 11217, Taiwan

Location

Novartis Investigative Site

Bursa, Gorukle, 16059, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Mental Disorders; Mood Disorders; Depression; Suicide; Suicidal Ideation; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Depressive Disorder; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: July 20, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: April 22, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

ES (6); PL (5); TU (3); CA (1); DE (2); JP (3); AR (1); BR (2); US (6); ME (3); MY (2); NL (1); RU (2); TW (2)