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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
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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
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Secondary ID [1]
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CMIJ821A12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder With Suicidal Ideation With Intent
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Condition category
Condition code
Mental Health
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Depression
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Mental Health
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Suicide
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS)
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Assessment method [1]
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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 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 will be collected electronically by qualified personnel
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Timepoint [1]
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Baseline (first infusion) at 24 hours and up to 52 weeks
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Secondary outcome [1]
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Number and severity of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI)
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Assessment method [1]
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Treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) will be collected at all study visits
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Timepoint [1]
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Baseline up to 6 weeks
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Secondary outcome [2]
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Pharmacokinetics (PK) of MIJ821 in plasma
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Assessment method [2]
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PK parameters of MIJ821 in plasma after 1st infusion described by AUClast, Cmax, Tmax and after each other infusion described by Cmax and Tmax. In order to better define the PK profile, the timing of the PK sample collection may be altered based on emergent data.
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Timepoint [2]
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Baseline up to 52 weeks
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Secondary outcome [3]
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Percentage of participants meeting response criteria of =50% reduction
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Assessment method [3]
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Response criteria of =50% reduction from baseline in MADRS total score over time in the Core Period.
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Timepoint [3]
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Baseline up to 6 weeks
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Secondary outcome [4]
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Percentage of participants meeting criteria for sustained response of =50% reduction
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Assessment method [4]
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Sustained response from baseline in MADRS total score for a period of at least four weeks in the Core Period
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Timepoint [4]
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Baseline up to 6 weeks
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Secondary outcome [5]
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Percentage of participants meeting remission criteria of MADRS total score of =12
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Assessment method [5]
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Remission criteria of MADRS total score of =12 over time in the Core Period
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Timepoint [5]
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Baseline up to 6 weeks
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Secondary outcome [6]
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Percentage of participants meeting sustained remission criteria of MADRS total score of =12
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Assessment method [6]
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Remission criteria of MADRS total score of =12 sustained for a period of at least four weeks in the Core Period
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Timepoint [6]
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Baseline up to 6 weeks
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Secondary outcome [7]
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Percentage of participants meeting criteria for relapse in the Extension Period
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Assessment method [7]
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Relapse for all patients meeting criteria for relapse over fixed period in the Extension Period
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Timepoint [7]
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From 6 weeks up to 52 weeks
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Secondary outcome [8]
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Percentage of relapsing participants meeting response criteria or remission criteria after the first infusion
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Assessment method [8]
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Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period
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Timepoint [8]
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From 6 weeks up to 52 weeks
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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
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Minimum age
18
Years
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/09/2023
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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United States of America
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Texas
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Argentina
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Buenos Aires
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Brazil
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Ceara
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Brazil
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Ontario
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Germany
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Frankfurt
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Germany
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Muenchen
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Aichi
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Japan
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Tokyo
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Malaysia
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Negeri Sembilan
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Malaysia
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Kuala Lumpur
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Nuevo Leon
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Mexico
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Groningen
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Lodzkie
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Gdansk
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Swiecie n/W
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Russian Federation
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Moscow
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Catalunya
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Barcelona
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Taipei
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Gorukle
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TUR
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04722666
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Trial related presentations / publications
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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
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04722666
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