A multi-center, randomized, subject and... — Clinical Trial Details

Randomized, double-blind, parallel-group Phase II study in 66 adults with treatment-resistant depression comparing multiple MIJ821 intravenous dose cohorts against placebo and an active ketamine comparator; single IV infusion with primary efficacy assessment at 24 hours post-infusion.

Key secondary assessments include dissociative effects, mania risk, melancholic and mixed‑mood symptom effects, anxiety, suicidality, and pharmacokinetics; scheduled assessments at 24 hours, 48 hours and 6 weeks.

IMPs: MIJ821 (lyophilisate for solution for infusion; product code MIJ821; concentration 20 mg) administered IV; active comparator KETOLAR (ketamine) IV solution 50 mg/ml; matching placebo IV solution used.

Participants

Ages

18 – 64

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Signed informed consent.
Male and female subjects, 18 to 65 years of age (inclusive) at screening.
DSM-5 defined major depressive episode at the time of screening.
Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 at baseline.
Failure to respond to two or more antidepressant treatments, at least one in the current depressive episode, with adequate dose and duration.
Stable dose of psychotropic drugs for at least 2 weeks prior to randomization if applicable.
No new antidepressant initiated ≤4 weeks before baseline (≤6 weeks if fluoxetine).
At least one prior clinical depressive episode (recurrent major depressive disorder).
Able to communicate well and comply with study requirements.

Exclusion Criteria

Any prior or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder.
Current alcohol or substance use (other than nicotine or caffeine) meeting DSM-5 criteria for addiction within the past month.
Prior suicidality caused by or associated with ketamine, as identified by prior psychiatric history and corroborated by records or third-party report where available.
Acute serious and/or imminent suicidal ideation and/or intent within the prior 2 weeks, or any suicide attempt within the prior 4 weeks at screening.
Use of other investigational drugs at randomization or within 30 days or 5 half-lives, whichever is longer.
Current pregnancy or lactation.
Positive HIV, Hepatitis B or C test.
Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment baseline.
History of multiple and recurring allergies or allergy to the investigational compound/class.
History of malignancy within the past 3 years (except localized basal cell carcinoma or in-situ cervical cancer).
Women of child-bearing potential must use highly effective contraception during dosing and for 1 week after stopping investigational drug.
History of hypersensitivity to study treatments or excipients.
Current diagnosis of borderline personality disorder or antisocial personality disorder.
Current acute depressive episode lasting >2 years continuously.
Considered by investigator to be an unsuitable candidate for the study.

Company

Product

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A multi-center, randomized, subject and investigator-blinded, placebo-controlled, active comparator, parallel-group proof of concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of MIJ821 in patients with treatment-resistant depression

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

MIJ821 cohort 1

Interventions

MIJ821 cohort 2

Interventions

MIJ821 cohort 3

Interventions

MIJ821 cohort 4

Interventions

Ketamine (KETOLAR)

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details