Antidepressant Trial With P2X7 Antagonist JNJ-54175446
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Depression is one of the most important causes of disability in the world today, with major
personal, social and economic costs. Although some moderately effective drug treatments are
already available, about a third of patients with major depressive disorder (MDD) remain
depressed despite current treatment.
There is growing evidence that inflammation - the response of the body's immune system to
physical and social stresses - can cause depressive symptoms in some patients. It is
therefore predicted that anti-inflammatory drugs could have anti-depressant effects and the
research team aims to test this using a new drug, JNJ-54175446, which blocks the activity of
a receptor called P2X7. P2X7 is present on many immune cells and plays a key role in the
release of inflammatory molecules during stress, which may be linked to stress-related
depression.
The research team will recruit approximately up to 142 participants with MDD to this clinical
trial. Patients will have moderate-severe depressive symptoms despite ongoing treatment with
a conventional anti-depressant drug, and they will have blood test results at screening that
indicate they are likely to have active P2X7 signalling in the brain. Eligible participants
will be randomly allocated to receive either 50mg/day JNJ-54175446 or placebo for 8 weeks.
Participants will be assessed at weeks 2, 5 and 8 using a standard clinical depression scale
and the scores compared between those treated with placebo and those treated with
JNJ-54175446. To understand more about the effects of JNJ-54175446 on the immune system and
the brain, patients will also complete additional blood tests, questionnaires and magnetic
resonance imaging (MRI) brain scans at different visits throughout the trial. The trial will
be carried out across 5 centres in the UK.