Major Depressive Disorder With Suicidal Ideation With IntentPhase 2NCT04722666
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 Phase 2 study testing MIJ821 Intravenous Injection in people with Major Depressive Disorder With Suicidal Ideation With Intent, run by Novartis Pharmaceuticals at 39 sites in 14 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder With Suicidal Ideation With Intent
- What is being tested?
- MIJ821 Intravenous Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 39 sitesin 14 countries
- Study dates
- 20 Jul 2021to 26 Sep 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
39 sites in 14 countries.
39 sites in 14 countries
United States6 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
InSite Clinical Research
DeSoto, Texas, 75115
University of Connecticut Health Center
Farmington, Connecticut, 06030-3100
Research Centers of America LLC
Oakland Park, Florida, 33334
Centers for Behavioral Research
Rockville, Maryland, 20850
Spain6 sites
Novartis Investigative Site
Araba, 01004
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Palma, Balearic Islands, 07120
Poland5 sites
Novartis Investigative Site
Bialystok, 15 276
Novartis Investigative Site
Gdansk, 80-214
Novartis Investigative Site
Gmina Świecie, 86-100
Novartis Investigative Site
Lodz, Łódź Voivodeship, 91-229
Novartis Investigative Site
Pruszków, Masovian Voivodeship, 05-802
Japan3 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138519
Novartis Investigative Site
Kodaira, Tokyo, 187-8551
Novartis Investigative Site
Toyoake, Aichi-ken, 470-1168
Mexico3 sites
Novartis Investigative Site
Mazatlán, Sinaloa, 82103
Novartis Investigative Site
Monterrey, Nuevo León, 64460
Novartis Investigative Site
San Luis Potosí City, 78213
Turkey (Türkiye)3 sites
Novartis Investigative Site
Bursa, Nilufer, 16059
Novartis Investigative Site
Istanbul, Fatih, 34098
Novartis Investigative Site
Izmir, 35100
Brazil2 sites
Novartis Investigative Site
Fortaleza, Ceará, 60430-270
Novartis Investigative Site
São Paulo, 09726-150
Germany2 sites
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
Novartis Investigative Site
Munich, Bavaria, 81377
Malaysia2 sites
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Seremban, Negeri Sembilan, 70300
Russia2 sites
Novartis Investigative Site
Moscow, 107258
Novartis Investigative Site
Moscow, 115419
Taiwan2 sites
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
About this study
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
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
Read the detailed description
The main purpose of this study was 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 for 6 weeks (3 infusions) 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 explored 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 consisted 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 explored durability of the effect of the study treatment and the effect of MIJ821 on relapse rate, as well as safety of MIJ821 administration.
Those patients that responded to treatment at the end of the Core period were followed for up to a 52-week Extension period and were allowed to be retreated due to a relapse once with the same active treatment regimen as in the Core period (participants treated with placebo in the Core period were randomly switched to an MIJ821 regimen).
- Being tested
- MIJ821 Intravenous Injection, Placebo Intravenous Injection
- 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
- Medical subject headings
- Depressive Disorder, Major, Mental Disorders, Mood Disorders, Depression, Suicide, Suicidal Ideation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIJ821 Intravenous InjectionDrug
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 Intravenous InjectionDrug
40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: MIJ821 Intravenous Injection |
| Placebo | Placebo comparator | 40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29 Receives: 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 Receives: 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 Receives: Drug: MIJ821 Intravenous Injection; Drug: Placebo Intravenous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 0 - 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 was collected electronically by qualified personnel.
Since the MADRS total score at 24 hours was evaluated post the single first infusion (prior to the second infusion), the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Measured: Baseline, 24 hours
Secondary outcomes (10)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) During the Core Period
Treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) in Core period
Measured: 6 weeks
AUClast - Pharmacokinetics (PK) of MIJ821 in Plasma
AUClast of MIJ821 in plasma after 1st infusion. AUClast is the Area Under the Curve (AUC) from time zero to the last measurable concentration sampling time (tlast). Since PK was evaluated post the single first infusion, the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Measured: Pre-dose, 20min, 40min, 4hours and 24hours post 1st infusion
Cmax - Pharmacokinetics (PK) of MIJ821 in Plasma
Cmax of MIJ821 in plasma after 1st infusion. AUClast is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. Since PK was evaluated post the single first infusion, the bi-weekly and single dosing regimens of the same dose level are pooled as one arm for 0.048 mg/kg and 0.16 mg/kg.
Measured: Pre-dose, 20min, 40min, 4hours and 24hours post 1st infusion
Number of Participants Meeting Response Criteria of ≥50% Reduction in MADRS Total Score.
Response criteria of ≥50% reduction from baseline in MADRS total score over time in the Core Period.
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 has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Measured: 6 weeks
Number of Participants Meeting Criteria for Sustained Response of ≥50% Reduction in MADRS Total Score
Sustained response (≥50% reduction from baseline) from baseline in MADRS total score for a period of at least four weeks in the Core Period.
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 has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Measured: 6 weeks
Number of Participants Meeting Remission Criteria of MADRS Total Score of ≤12
Remission criteria of MADRS total score of ≤12 over time in the Core Period. 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 has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Measured: 6 weeks
Number of Participants Meeting Sustained Remission Criteria of MADRS Total Score of ≤12
Remission criteria of MADRS total score of ≤12 sustained for a period of at least four weeks in the Core Period.
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 has a total possible score of 0 - 60. Higher scores represent a more severe condition.
Measured: 6 weeks
Number of Participants Meeting Criteria for Relapse in the Extension Period
For participants classified as responders in the core period who entered the extension period. Response is defined as a ≥ 50% reduction from the baseline MADRS score at any visit during the study.
All participants meeting criteria for relapse over fixed period in the Extension Period. A relapse manifests as the appearance of new depressive symptoms or worsening of previously stable or improving MDD symptoms. During the Extension Period, participants experiencing deterioration must be assessed by the treating physician and the relapse must be confirmed by assessment with MADRS during scheduled or unscheduled visit.
Measured: From 6 weeks up to 58 weeks
Number of Relapsing Participants Meeting Response Criteria After the First Retreatment Infusion in the Extension Period
Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period.
Response criteria (>=50% reduction from baseline in MADRS total score). Reinfusions are given at Day 1, 15 and 29 after relapse.
Measured: Up to 52 weeks after first retreatment infusion. Timepoints are relative to first retreatment (R) infusion for each patient, including Follow Up (F/U).
Number of Relapsing Participants Meeting Remission Criteria After the First Retreatment Infusion in the Extension Period
Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period.
Remission criteria (MADRS total score <=12). Reinfusions are given at Day 1, 15 and 29 after relapse.
Measured: Up to 52 weeks after first retreatment infusion. Timepoints are relative to first retreatment (R) infusion for each patient, including Follow Up (F/U).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start20 Jul 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Why it stopped: Terminated by Novartis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive Disorder With Suicidal Ideation With IntentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722666
- Sponsor's protocol ID
- CMIJ821A12201
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2021
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/