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

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

ClinicalTrials.gov Identifier: NCT04722666

Novartis Reference Number: CMIJ821A12201

Last Update: Mar 15, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Major Depressive Disorder With Suicidal Ideation With Intent
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Jul 20, 2021
Completion date 
Jan 30, 2024
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35294-3300
Alabama
United States
Novartis Investigative Site
Recruiting
Garden Grove, 92845
California
United States
Novartis Investigative Site
Recruiting
Farmington, 06030-3100
Connecticut
United States
Novartis Investigative Site
Recruiting
Oakland Park, 33334
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30331
Georgia
United States
Novartis Investigative Site
Recruiting
Rockville, 20850
Maryland
United States
Novartis Investigative Site
Recruiting
Columbus, 43210
Ohio
United States
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Japan
Novartis Investigative Site
Recruiting
Toyoake-city, 470-1168
Aichi
Japan
Novartis Investigative Site
Recruiting
Bunkyo-ku, 113-8519
Tokyo
Japan
Novartis Investigative Site
Recruiting
Kodaira, 187-8551
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 157-8577
Tokyo
Japan
Malaysia
Novartis Investigative Site
Recruiting
Seremban, 70300
Negeri Sembilan
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 59100
-
Malaysia
Mexico
Novartis Investigative Site
Recruiting
Monterrey, 64460
Nuevo Leon
Mexico
Novartis Investigative Site
Recruiting
San Luis Potosi, 78213
-
Mexico
Netherlands
Novartis Investigative Site
Recruiting
Groningen, 9713 GZ
-
Netherlands
Poland
Novartis Investigative Site
Recruiting
Lodz, 91-229
Lodzkie
Poland
Novartis Investigative Site
Recruiting
Pruszkow, 05-802
Mazowieckie
Poland
Novartis Investigative Site
Recruiting
Choroszcz, 16-070
-
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80 952
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 107258
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115419
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Hospitalet de Llobregat, 08907
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Palma De Mallorca, 07120
Islas Baleares
Spain
Novartis Investigative Site
Recruiting
Vitoria-Gasteiz, 01004
Pais Vasco
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08025
-
Spain
Turkey
Novartis Investigative Site
Recruiting
Bursa, 16059
Gorukle
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Adana,
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35100
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
Preston, PR2 9HT
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]