A randomized, double-blind, placebo-controlled,... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Signed informed consent obtained prior to participation.
Male and female participants, 18–65 years inclusive at screening.
Diagnosis of recurrent major depressive disorder with current major depressive episode ≥8 weeks by DSM-5, confirmed by MINI and clinical psychiatric evaluation.
MADRS ≥24 at screening and before randomization (Day 1).
Failure to respond to 2–5 antidepressant treatments (at least two different agents, at least one in current episode) with adequate dose/duration (≥6 weeks) as per MGH-ATRQ; prior failure to esketamine/ketamine/arketamine excluded.
Participant agrees to receive pharmacological standard of care during trial per treating physician and protocol recommendations.
Stable dose of other psychotropic drugs (no change for ≥6 weeks prior to baseline) if applicable; antidepressant dose stable ≥4 weeks before baseline; no new antidepressant ≤6 weeks before baseline; no new psychotherapy ≤4 weeks before baseline.
Able to communicate and comply with study requirements.

Exclusion Criteria

Current acute depressive episode >2 years continuously, or ECT, VNS or DBS within 1 year prior to screening.
Prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder (per MINI Modules C and K).
Acute alcohol or substance use disorder or withdrawal requiring detoxification, or detoxification within 1 month prior to screening (per MINI Modules I and J).
Current borderline or antisocial personality disorder (per MINI Modules Y and P).
Current clinical diagnosis of autism, dementia, or intellectual disability.
History of suicide attempt or suicidal behaviour within 1 year prior to screening; suicidal ideation with intent at screening or baseline (C-SSRS Q4 or Q5 positive).
Significant renal insufficiency (eGFR <40 mL/min/1.73 m2).
Use of other investigational drugs at screening or within 30 days or 5 half-lives, whichever is longer.
Hypersensitivity to study treatment or excipients or to drugs affecting the NMDA receptor.
Active HBV, HCV, HIV, or active COVID-19 infection.
History of seizures (childhood febrile seizures not exclusionary).
Cardiac or repolarisation abnormality: resting QTcF ≥450 ms (male) or ≥460 ms (female); risk factors for Torsades de Pointes (eg uncorrected hypokalaemia/hypomagnesaemia, history of heart failure, symptomatic bradycardia).
Mean systolic BP >140 mmHg or diastolic BP >90 mmHg at screening or pre-dose, or past hypertensive crisis.
History of haemorrhagic stroke or known cerebrovascular disorders or aneurysmal vascular disease.
Pregnancy or lactation at screening or baseline; women of childbearing potential must use highly effective contraception during dosing and for 1 week after; sexually active males must use condoms during dosing and for 1 week after and must not donate sperm during this period.
Any other condition that in the investigator's opinion would put participant safety at risk or affect compliance (see protocol for full criteria).

Company

Product

Legal

A randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single subcutaneous MIJ821 injection in addition to standard of care in participants with treatment-resistant depression

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

MIJ821 dose A

Interventions

MIJ821 dose B

Interventions

MIJ821 dose C

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details