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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder With Suicidal Ideation With Intent

In brief

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

Key facts

Study ID

NCT04722666

Run by

Novartis Pharmaceuticals

People needed

199

Starts

2021-07-20

Expected to finish

2023-09-26

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• History of seizures. Note: childhood febrile seizures are not exclusionary
• Participants with current 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
• Current Monoamine oxidase inhibitors (MAOIs) 14 days before Screening
• known worsening or new appearance of suicidal ideation or behavior during a prior treatment, or within 2 months after last administration
• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Research Centers of America LLC — Oakland Park, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Centers for Behavioral Research — Rockville, Maryland, United States
• InSite Clinical Research — DeSoto, Texas, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — São Paulo, Brazil
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Munich, Bavaria, Germany
• Novartis Investigative Site — Frankfurt am Main, Hesse, 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 — Gmina Świecie, Poland

Full record on ClinicalTrials.gov

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