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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04722666
Recruitment Status : Terminated (Terminated by Novartis)
First Posted : January 25, 2021
Last Update Posted : November 1, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder With Suicidal Ideation With Intent Drug: MIJ821 Intravenous Injection Drug: Placebo Intravenous Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Dose-ranging Trial to Investigate Efficacy and Safety of Intravenous MIJ821 Infusion 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
Actual Study Start Date : July 20, 2021
Actual Primary Completion Date : September 20, 2023
Actual Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: 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
Drug: 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

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

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

Experimental: 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
Drug: 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

Placebo Comparator: Placebo
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29
Drug: Placebo Intravenous Injection
40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

Experimental: 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
Drug: 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

Drug: Placebo Intravenous Injection
40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

Experimental: 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
Drug: 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

Drug: Placebo Intravenous Injection
40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29




Primary Outcome Measures :
  1. Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (first infusion) at 24 hours and up to 52 weeks ]
    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


Secondary Outcome Measures :
  1. Number and severity of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI) [ Time Frame: Baseline up to 6 weeks ]
    Treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) will be collected at all study visits

  2. Pharmacokinetics (PK) of MIJ821 in plasma [ Time Frame: Baseline up to 52 weeks ]
    PK parameters of MIJ821 in plasma after 1st infusion described by AUClast, Cmax, Tmax and after each other infusion described by Cmax and Tmax. In order to better define the PK profile, the timing of the PK sample collection may be altered based on emergent data.

  3. Percentage of participants meeting response criteria of ≥50% reduction [ Time Frame: Baseline up to 6 weeks ]
    Response criteria of ≥50% reduction from baseline in MADRS total score over time in the Core Period.

  4. Percentage of participants meeting criteria for sustained response of ≥50% reduction [ Time Frame: Baseline up to 6 weeks ]
    Sustained response from baseline in MADRS total score for a period of at least four weeks in the Core Period

  5. Percentage of participants meeting remission criteria of MADRS total score of ≤12 [ Time Frame: Baseline up to 6 weeks ]
    Remission criteria of MADRS total score of ≤12 over time in the Core Period

  6. Percentage of participants meeting sustained remission criteria of MADRS total score of ≤12 [ Time Frame: Baseline up to 6 weeks ]
    Remission criteria of MADRS total score of ≤12 sustained for a period of at least four weeks in the Core Period

  7. Percentage of participants meeting criteria for relapse in the Extension Period [ Time Frame: From 6 weeks up to 52 weeks ]
    Relapse for all patients meeting criteria for relapse over fixed period in the Extension Period

  8. Percentage of relapsing participants meeting response criteria or remission criteria after the first infusion [ Time Frame: From 6 weeks up to 52 weeks ]
    Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722666


Locations
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United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-3300
United States, Connecticut
Novartis Investigative Site
Farmington, Connecticut, United States, 06030-3100
United States, Florida
Novartis Investigative Site
Oakland Park, Florida, United States, 33334
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30331
United States, Maryland
Novartis Investigative Site
Rockville, Maryland, United States, 20850
United States, Texas
Novartis Investigative Site
DeSoto, Texas, United States, 75115
Argentina
Novartis Investigative Site
Buenos Aires, Argentina, C1429DUC
Brazil
Novartis Investigative Site
Fortaleza, Ceara, Brazil, 60430-270
Novartis Investigative Site
Sao Bernardo do Campo, Sao Paulo, Brazil, 09726-150
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5B 1W8
Germany
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Muenchen, Germany, 81377
Japan
Novartis Investigative Site
Toyoake-city, Aichi, Japan, 470-1168
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8519
Novartis Investigative Site
Kodaira, Tokyo, Japan, 187-8551
Malaysia
Novartis Investigative Site
Seremban, Negeri Sembilan, Malaysia, 70300
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Mexico
Novartis Investigative Site
Monterrey, Nuevo Leon, Mexico, 64460
Novartis Investigative Site
Mazatlan, Sinaloa, Mexico, 82140
Novartis Investigative Site
San Luis Potosi, Mexico, 78213
Netherlands
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Poland
Novartis Investigative Site
Lodz, Lodzkie, Poland, 91-229
Novartis Investigative Site
Pruszkow, Mazowieckie, Poland, 05-802
Novartis Investigative Site
Bialystok, Poland, 15 276
Novartis Investigative Site
Gdansk, Poland, 80 952
Novartis Investigative Site
Swiecie n/W, Poland, 86-100
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 107258
Novartis Investigative Site
Moscow, Russian Federation, 115419
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Palma De Mallorca, Islas Baleares, Spain, 07120
Novartis Investigative Site
Vitoria-Gasteiz, Pais Vasco, Spain, 01004
Novartis Investigative Site
Barcelona, Spain, 08025
Novartis Investigative Site
Barcelona, Spain, 08041
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10048
Novartis Investigative Site
Taipei, Taiwan, 11217
Turkey
Novartis Investigative Site
Bursa, Gorukle, Turkey, 16059
Novartis Investigative Site
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site
Izmir, Turkey, 35100
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04722666    
Other Study ID Numbers: CMIJ821A12201
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: November 1, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Suicidal Ideation
Mood Disorders
Mental Disorders
Behavioral Symptoms
Suicide
Self-Injurious Behavior