Clinical TrialTreatment-Resistant Depression (TRD)PlaceboRecruiting

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

Randomised, double-blind, placebo-controlled, parallel-group Phase II trial (n=56) testing a single subcutaneous MIJ821 injection plus standard care versus placebo in participants with treatment-resistant depression (TRD).

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Target Enrollment
56 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

This Phase II, multicentre, double-blind, randomised, placebo-controlled trial evaluates efficacy, safety, tolerability and pharmacokinetics of a single subcutaneous injection of MIJ821 added to standard of care in adults with treatment-resistant depression.

Primary endpoint is change in MADRS total score at 24 hours post dose versus baseline; secondary endpoints include safety/TEMs, CADSS, MOAA/S, C-SSRS, PK parameters (AUC, Cmax, Tmax), and MADRS at Days 8, 15, 22 and 29.

Sponsor: Novartis Farmacéutica, S.A. (protocol CMIJ821B12201). Planned multinational sites include Spain, Japan, United States, Poland and Czechia; total planned enrollment ~56 participants.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

MIJ821 dose A

experimental

Single subcutaneous MIJ821 injection (dose group A).

Interventions

  • Compound
    via Subcutaneous• single dose• 1 doses total

    MIJ821 (single s.c. injection); concentration described as 20 mg in protocol; specific dose for this arm per protocol.

MIJ821 dose B

experimental

Single subcutaneous MIJ821 injection (dose group B).

Interventions

  • Compound
    via Subcutaneous• single dose• 1 doses total

    MIJ821 (single s.c. injection); specific dose per protocol.

MIJ821 dose C

experimental

Single subcutaneous MIJ821 injection (dose group C).

Interventions

  • Compound
    via Subcutaneous• single dose• 1 doses total

    MIJ821 (single s.c. injection); specific dose per protocol.

Placebo

inactive

Placebo solution for injection, subcutaneous.

Interventions

  • Placebo
    via Subcutaneous• single dose• 1 doses total

    Placebo matching solution for subcutaneous injection.

Participants

Ages
18 – 65
Sexes
Male & Female

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).

Study Protocol, Arms & Participants

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Study Details

Locations

SpainJapanUnited StatesPolandCzechia

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