Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04722666




Registration number
NCT04722666
Ethics application status
Date submitted
21/01/2021
Date registered
25/01/2021
Date last updated
1/11/2023

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
CMIJ821A12201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder With Suicidal Ideation With Intent 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MIJ821 Intravenous Injection
Treatment: Drugs - Placebo Intravenous Injection

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

Experimental: MIJ821 (mg/kg) - low dose - MIJ821 (mg/kg) low dose 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

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

Placebo Comparator: Placebo - 40 minutes IV infusion of 0.9% sodium chloride on Day 1, 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

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


Treatment: Drugs: 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

Treatment: Drugs: Placebo Intravenous Injection
40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
Baseline (first infusion) at 24 hours and up to 52 weeks
Secondary outcome [1] 0 0
Number and severity of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI)
Timepoint [1] 0 0
Baseline up to 6 weeks
Secondary outcome [2] 0 0
Pharmacokinetics (PK) of MIJ821 in plasma
Timepoint [2] 0 0
Baseline up to 52 weeks
Secondary outcome [3] 0 0
Percentage of participants meeting response criteria of =50% reduction
Timepoint [3] 0 0
Baseline up to 6 weeks
Secondary outcome [4] 0 0
Percentage of participants meeting criteria for sustained response of =50% reduction
Timepoint [4] 0 0
Baseline up to 6 weeks
Secondary outcome [5] 0 0
Percentage of participants meeting remission criteria of MADRS total score of =12
Timepoint [5] 0 0
Baseline up to 6 weeks
Secondary outcome [6] 0 0
Percentage of participants meeting sustained remission criteria of MADRS total score of =12
Timepoint [6] 0 0
Baseline up to 6 weeks
Secondary outcome [7] 0 0
Percentage of participants meeting criteria for relapse in the Extension Period
Timepoint [7] 0 0
From 6 weeks up to 52 weeks
Secondary outcome [8] 0 0
Percentage of relapsing participants meeting response criteria or remission criteria after the first infusion
Timepoint [8] 0 0
From 6 weeks up to 52 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2023
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Brazil
State/province [8] 0 0
Ceara
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Muenchen
Country [13] 0 0
Japan
State/province [13] 0 0
Aichi
Country [14] 0 0
Japan
State/province [14] 0 0
Tokyo
Country [15] 0 0
Malaysia
State/province [15] 0 0
Negeri Sembilan
Country [16] 0 0
Malaysia
State/province [16] 0 0
Kuala Lumpur
Country [17] 0 0
Mexico
State/province [17] 0 0
Nuevo Leon
Country [18] 0 0
Mexico
State/province [18] 0 0
Sinaloa
Country [19] 0 0
Mexico
State/province [19] 0 0
San Luis Potosi
Country [20] 0 0
Netherlands
State/province [20] 0 0
Groningen
Country [21] 0 0
Poland
State/province [21] 0 0
Lodzkie
Country [22] 0 0
Poland
State/province [22] 0 0
Mazowieckie
Country [23] 0 0
Poland
State/province [23] 0 0
Bialystok
Country [24] 0 0
Poland
State/province [24] 0 0
Gdansk
Country [25] 0 0
Poland
State/province [25] 0 0
Swiecie n/W
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Moscow
Country [27] 0 0
Spain
State/province [27] 0 0
Catalunya
Country [28] 0 0
Spain
State/province [28] 0 0
Islas Baleares
Country [29] 0 0
Spain
State/province [29] 0 0
Pais Vasco
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei
Country [32] 0 0
Turkey
State/province [32] 0 0
Gorukle
Country [33] 0 0
Turkey
State/province [33] 0 0
TUR
Country [34] 0 0
Turkey
State/province [34] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04722666
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04722666