depression Major Depressive Disorder in subjects who have suicidal ideation with intent
Conditions
Interventions
Intravenous MIJ821 administered as a 40-min infusion in addition to
comprehensive standard of care (SoC)
Treatment groups (2:1:2:2:2:2:2 ratio):
- placebo every other week
- MIJ821 0.0048 mg/kg ev
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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) body weight from 50 to 120 kg (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 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.
Exclusion criteria
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.Known worsening or new appearance of suicidal ideation or behavior during a prior treatment with ketamine or esketamine or within 2 months after last ketamine or esketamine administration 8. Participants taking medications prohibited by the protocol 9. Intake of the following medications/ psychotherapy: a. Esketamine or Ketamine 2 months before Screening b. Monoamine oxidase inhibitors (MAOIs) 14 days before Screening 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in MADRS total score at 24 hours after the start of the first infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| * Number and severity of treatment-emergent adverse events (TEAEs), including AEs of special interest in the Core Period * Proportion of participants meeting response criteria (>=50%reduction from baseline in MADRS total score) over time in the Core Period. Proportion of participants meeting criteria for sustained response (>=50% reduction from baseline in MADRS total score sustained for a period of at least four weeks) in the Core Period Proportion of participants meeting remission criteria (MADRS total score of | — |
Countries
Netherlands
Outcome results
None listed