Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid… (NCT04722666) | Clinical Trial Compass
TerminatedPhase 2
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: Terminated by Novartis
United States, Argentina, Brazil199 participantsStarted 2021-07-20
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that tell us anything important about whether MIJ821 is safe or effective for my situation?
2Since this was a Phase 2 trial that has been terminated, what does that mean for how much we actually know about MIJ821's safety and benefits compared to treatments that are already approved for depression with suicidal thoughts?
3The trial was measuring rapid symptom reduction using the MADRS depression scale — are there any already-approved treatments, like certain antidepressants or ketamine-based therapies, that have stronger evidence for quickly reducing suicidal ideation that we should consider first?
4Since the trial is no longer recruiting, is MIJ821 available through any other pathway, like a compassionate use or expanded access program, and would that even be appropriate given my current level of risk?
5Given that this study was specifically for people with suicidal ideation with intent, which is a serious and urgent situation, what is your recommended treatment plan for me right now while we evaluate whether any investigational options make sense?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Total Score of the Montgomery Åsberg Depression Rating Scale (MADRS)
. 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 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: