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

This randomised, double-blind, placebo-controlled, parallel-group trial (n=55) sponsored by Novartis Farmacéutica, S.A., in collaboration with Novartis Pharma AG, aims to evaluate the efficacy, safety, tolerability, and pharmacokinetics of a single subcutaneous injection of MIJ821 (NMDA receptor activity like ketamine) in addition to standard care for participants with treatment-resistant depression (TRD).

The trial, conducted in Spain, involves adults aged 18-65, including both genders, with recurrent major depressive disorder (MDD) and a current major depressive episode lasting at least 8 weeks. Participants must have failed to respond to 2 or more antidepressant treatments, and their antidepressant treatment should be stable for at least 4 weeks before baseline.

The primary endpoint is the change in MADRS total score 24 hours after the subcutaneous injection, compared to baseline. Secondary endpoints include safety assessments, pharmacokinetic properties, and the dose-response relationship of MIJ821.

The trial involves six sites in Spain and an additional six sites across Japan, the United States, Poland, and Czechia. The trial is expected to last approximately 1 year and 5 months, with the last patient’s last visit marking the end.

The trial is also registered in other countries: https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005992-38/PL

Topic Treatment-Resistant Depression Depression
Compound Placebo Ketamine
Country Spain Poland
Visit trial
Status Planned
Results Published No
Start date 29 August 2022
End date 25 October 2025
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 55
Sex All
Age 18- 65
Therapy No

Trial Details

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

Trial Number CMIJ821B12201

Sponsors & Collaborators

Novartis Pharmaceuticals
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Data attribution

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