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Experimental drug MIJ821 aims to quickly ease depression and suicidal urges

NCT ID NCT04722666

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called MIJ821, given as an IV infusion, to see if it could quickly reduce depression symptoms in people with major depressive disorder who also have active suicidal thoughts. About 199 adults aged 18 to 65 took part, receiving either MIJ821 or a placebo alongside standard care. The trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MIJ821
What this could lead to
If it works, this could point toward a fast-acting treatment for severe depression with suicidal thoughts.
What could go wrong
The trial was terminated early, so results are limited. It is a Phase 2 study, and the drug may not prove effective or safe in larger groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

199 people

The number who actually took part.

Started

Jul 2021

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 current 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. Current Monoamine oxidase inhibitors (MAOIs) 14 days before Screening 3. known worsening or new appearance of suicidal ideation or behavior during a prior treatment, or within 2 months after last administration 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.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder mood disorder psychiatric disorder Self-Injurious Behavior Suicidal Ideation Suicide

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder with suicidal ideation with intent

Contacts and locations

Locations

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • Centers for Behavioral Research

    Rockville, Maryland, 20850, United States

  • InSite Clinical Research

    DeSoto, Texas, 75115, United States

  • Novartis Investigative Site

    Buenos Aires, C1429DUC, Argentina

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430-270, Brazil

  • Novartis Investigative Site

    São Paulo, 09726-150, Brazil

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8, Canada

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 470-1168, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    Kodaira, Tokyo, 187-8551, Japan

  • Novartis Investigative Site

    Seremban, Negeri Sembilan, 70300, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Mazatlán, Sinaloa, 82103, Mexico

  • Novartis Investigative Site

    San Luis Potosí City, 78213, Mexico

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Pruszków, Masovian Voivodeship, 05-802, Poland

  • Novartis Investigative Site

    Bialystok, 15 276, Poland

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Gmina Świecie, 86-100, Poland

  • Novartis Investigative Site

    Lodz, Łódź Voivodeship, 91-229, Poland

  • Novartis Investigative Site

    Moscow, 107258, Russia

  • Novartis Investigative Site

    Moscow, 115419, Russia

  • Novartis Investigative Site

    Palma, Balearic Islands, 07120, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Araba, 01004, Spain

  • Novartis Investigative Site

    Barcelona, 08025, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Bursa, Nilufer, 16059, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Research Centers of America LLC

    Oakland Park, Florida, 33334, United States

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300, United States

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-3100, United States