A study of JNJ-42847922 in people with major depressive disorder; v1
Research type
Research Study
Full title
An exploratory, multicenter, placebo-controlled, randomized, double-blind study to investigate the antidepressant mechanism-of-action of JNJ-42847922 in subjects with major depressive disorder (HMR code: 17-507).
IRAS ID
234274
Contact name
Adeep Puri
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-002633-28
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
JNJ-42847922 (the study medicine) is an experimental treatment for major depressive disorder (MDD) and/or insomnia disorder. People with brain disorders, including those with mood disorders, often experience insomnia. That could be linked to production of too much of a substance called orexin, which is associated with arousal (wakefulness). The study medicine blocks the target (OX2R receptor) of orexin, stopping it from activating that target and causing too much wakefulness. We hope that the study medicine will reduce the amount of wakefulness that people with MDD experience, and improve the symptoms of MDD.
We'll give up to 138 people with MDD, aged 18-55 years, repeated doses of the study medicine given as a single dose of 20 mg or 40 mg for up to 8 weeks. Some participants will take dummy medicine instead of study medicine for all or some of the time. We’ll test the side effects and blood levels of the study medicine, and how it affects sleep, participants’ performance of a simple set of tasks, and the symptoms of MDD. We’ll study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine. We'll also study substances that may be linked to disease or to the way the body responds to the study medicine.
Participants will take up to 13 weeks to finish the study. They’ll make up to 9 outpatient visits, and stay overnight on the ward for 1 night during screening and for 2 nights on 2 occasions, during the study.A pharmaceutical company, Janssen Research & Development, is funding the study.
The study will take place in at least 14 centres worldwide: 4 in the UK, 9 in the EU and 1 in the USA are planned so far.REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/0024
Date of REC Opinion
5 Mar 2018
REC opinion
Further Information Favourable Opinion