* CMIJ821A12201 Major Depressive Disorder suicidal ideation with intent
Research type
Research Study
Full title
A double-blind, placebo-controlled, randomized dose-ranging trial to investigate efficacy and safety of intravenous MIJ821 infusion in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder in subjects who have suicidal ideation with intent
IRAS ID
290282
Contact name
Allan Young
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-003720-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 21 days
Research summary
Major depressive disorder (MDD) is the psychiatric diagnosis most commonly associated with suicide. Over the past 40 years research has led to the introduction of safer, better tolerated, and easier-to-prescribe antidepressants, most notably selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). Nevertheless, about 30 to 40% of patients with MDD fail to respond to these treatments. In addition, the onset to treatment response, even when effective, often takes at least 4 weeks, leading to greater suffering, expenses and suicidal risk. Therefore, there remains an ongoing high need for rapid acting, either more effective or better tolerated treatments that can in an effective way interrupt a depressive episode, reduce suicidality, and also able to prevent future depressive episodes.
This is a Phase IIb dose ranging study, which will consist of approximately 195 subjects globally, males and females; ages 18 to 65 inclusive. There will be approximately 12 subjects recruited in the UK across 3 hospital sites.
The study will consist of a Core Period (6 weeks) where patients will receive study treatment 3 times (once every other week) and an Extension Period that lasts a minimum of 8 weeks and a maximum of 52 weeks. In the Extension Period, the patient may receive study treatment again, depending on whether they relapse i.e. recurrence of depression confirmed by the Investigator. Overall, the study will take place over a minimum of 14 weeks and a maximum of 58 weeks.
The purpose of the study is to determine if the study treatment MIJ821 is rapidly reducing depression associated with thoughts of harming oneself when given with standard antidepressant medication. This study will investigate if the administration of several doses of MIJ821 is safe and efficacious for the treatment of this condition.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0144
Date of REC Opinion
11 Jun 2021
REC opinion
Further Information Favourable Opinion