A study to explore JNJ-61393215 in the treatment of depression
Research type
Research Study
Full title
Double-blind, placebo-controlled, multi-center study investigating the efficacy, safety and tolerability of JNJ-61393215 as adjunctive treatment in adults with major depressive disorder with anxious distress with suboptimal response to standard antidepressants.
IRAS ID
270677
Contact name
Aliya Asher
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2019-001683-29
Duration of Study in the UK
1 years, 11 months, 14 days
Research summary
Summary of Research
JNJ-61393215 (the study medicine) is a new treatment for major depressive disorder (MDD) with anxiety.
The brain currently has neurons which are multi-tasking constantly and regulate multiple functions within the body. The receptor (OX1R) in the brain creates complex emotional behaviour and there is evidence that when this receptor is continuously overactive, this can increase hyperarousal states such as panic attacks. This hyperarousal state may become a normalised way of life for some people.
There is existing non-clinical data which supports the potential need for a novel drug which inhibits the role of the receptor OX1R, to treat various anxiety disorders, addictive disorders and potentially depression.
In this study , 218 patients - who are aged between 18 and 64 , and have major depressive disorder (MDD) and anxious distress - will be enrolled . These patients will be given either a placebo (dummy drug) or study drug in 3 doses of 45 mg each for up to 6 weeks
We will test the side effects, amount of the study medicine in the blood and how it affects the MDD and anxious distress. We will study how genes (pieces of DNA) affects the way the body responds to or handles the medicine. We will also study substances that may be linked to the disease or to the way the body responds to the study medicine.
Participants will be in the study for a maximum of 12 weeks, and will be required to attend 6 outpatient visits and have 1 telephone call from an independent psychological rater (someone who can assess their level of MDD or anxious distress).
Janssen Research & Development (a pharmaceutical company) is funding the study. This will take place in 4 countries worldwide.REC name
Wales REC 1
REC reference
19/WA/0264
Date of REC Opinion
26 Sep 2019
REC opinion
Further Information Favourable Opinion