A study of JNJ-67953964 in people with major depressive disorder; v1

• Research type

  Research Study

• Full title

  A phase 2a randomized, double-blind, placebo-controlled, parallel-group, multi-center study investigating the efficacy, safety, tolerability and pharmacokinetics of JNJ-67953964 in subjects with major depressive disorder (HMR code: 19-501).

• IRAS ID

  261194

• Contact name

  Jeremy Dennison

• Contact email

  jdennison@hmrlondon.com

• Sponsor organisation

  Janssen Cilag International NV

• Eudract number

  2019-000695-41

• Clinicaltrials.gov Identifier

  NCT03559192

• Clinicaltrials.gov Identifier

  EDMS-ERI-158697750, 3.0, EDMS number

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  JNJ-67953964 (the study medicine) is an experimental treatment for major depressive disorder (MDD). We’re not sure what causes MDD, but we think that the symptoms may be linked to problems in the reward pathways in the brain.
  
  The brain contains chemical ‘switches’, which turn the reward pathways on and off. The study medicine works by blocking substances in the brain from binding to and activating one of those “off switches” (sites called kappa opioid receptors; KORs). Studies in animals showed that blocking KORs improved signs of low mood, depression and anxiety, so scientists think that blocking KORs might switch the reward pathways back on, and therefore help patients with MDD.

  We'll give up to 180 people with MDD, aged 18-64 years and who are taking 1 treatment for their depression, repeated doses of the study medicine given as a single dose of 10 mg for up to 11 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 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 16 weeks to finish the study. They’ll make up to 11 outpatient visits during the study.

  A pharmaceutical company, Janssen Research & Development, is funding the study.
  The study will take place in at least 46 centres worldwide: 5 in the UK, 4 in the EU (excluding the UK) and 37 other sites worldwide are currently planned.

• REC name

  HSC REC B

• REC reference

  19/NI/0097

• Date of REC Opinion

  27 Jun 2019

• REC opinion

  Further Information Favourable Opinion