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

This Phase IIa multi-center, randomized, subject, and investigator-blinded, placebo-controlled, active comparator, parallel-group proof-of-concept study (n=66) investigates the efficacy, safety, tolerability, and pharmacokinetics of MIJ821 (NMDA receptor activity like ketamine) in patients (aged 18-65) with treatment-resistant depression (TRD).

Conducted by Novartis Farmacéutica, S.A. in Spain, the trial utilizes MIJ821, a lyophilisate for solution for infusion, as the investigational medicinal product (IMP). The study assesses the total score of the Montgomery–Åsberg Depression Rating Scale (MADRS) as the primary endpoint 24 hours after the start of the infusion compared to baseline assessment. Secondary endpoints include various scales such as Young Mania Rating Scale, Bech-Rafaelsen melancholia scale, and Clinician-Administered Dissociative States Scale at different timepoints.

Exclusion criteria encompass diagnoses of bipolar disorder, schizophrenia, or schizoaffective disorder, and current substance use meeting DSM-5 addiction criteria. The trial involves two sites in Spain, with an anticipated duration of 11 months and 25 days, and aims to explore the potential of MIJ821 in managing TRD.

Note to self, results: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003002-12/results

Topic Treatment-Resistant Depression Depression
Compound Placebo Ketamine
Country Spain
Visit trial
Status Completed
Results Published Yes
Start date 12 April 2019
End date 23 March 2020
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 66
Sex All
Age 18- 64
Therapy No

Trial Details

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

Trial Number CMIJ821X2201

Sponsors & Collaborators

Novartis Pharmaceuticals
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Data attribution

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