Antidepressant Trial with P2X7 Antagonist JNJ-54175446 (ATP)

This trial aims to test whether a new anti-inflammatory drug has the potential to treat patients living with major depressive disorder (MDD) and whose symptoms remain despite current medications.

Background

Depression affects over 300 million people globally, and major depression disorder (MDD) is one of the main causes of severe disability. Symptoms of MDD often persist despite antidepressant drug therapy, possibly because currently available antidepressant drugs have a similar mechanism of action. It is therefore important to discover new drugs that work in a different way.

There is evidence to suggest that inflammation may be linked to depression and that anti-inflammatory mechanisms may offer a new approach to treating depression. This trial aims to test whether a new anti-inflammatory drug has the potential to treat patients suffering from depression who have not responded to their current medications.

Who can take part?

Due to the nature of clinical research, we have a strict set of eligibility criteria that need to be met before participation in the study is possible.

To take part you must:

• be between 18 and 60 years of age (inclusive)
• have a BMI between 18 and 36kg/m2
• be currently treated with an anti-depressant for at least 6 weeks
• still be experiencing symptoms of depression
• not have any medical disorders that affect your immune system
• not be pregnant, breastfeeding or trying for at least six months from enrolling

Please note, there are other criteria to meet to be eligible, we have only listed the ones that are easy for you to determine.

Participant involvement

• If you are eligible to take part, you will be randomly allocated to either the active drug group or the placebo (dummy drug) group. You will then have to take the allocated drug daily for about eight weeks, alongside your current antidepressant medication. We cannot tell you which group you have been allocated to.
• You will make 6 visits to the research centre over approximately 14 weeks.
• You will have to fast overnight (10hrs) before each visit.
• At the visits, you will be asked questions about your depression and mental health, and complete some computer tasks.
• You will also be required to provide blood and urine samples for various tests and undergo ECG[1] and MRI[2]
• You will also be required to complete some activities at home which include completing weekly questionnaires, providing saliva samples and wear a wrist activity monitor.

[1] Electrocardiogram (ECG): recording of the electrical activity of your heart

[2] Magnetic Resonance Imaging (MRI): a non-invasive procedure that uses radio-frequency and magnetic fields to produce images of your brain and body.

Potential benefits to participants

• If you have been allocated to the active group, you may experience some improvements in your depression symptoms. However, please note that you will not receive any more of the drug after the trial.
• You will be compensated for reasonable travel expenses.
• You will receive up to £500 for your time and effort in the trial. The exact amount will depend on the number of visits you have completed.

How to take part

If you would like more information or wish to take part in this research, please contact Sophie Bishop or Matthew Haynes on 02921 845879 or e-mail Sophie.Bishop@wales.nhs.uk or matthew.haynes2@wales.nhs.uk

Principle Investigator

Neil Harrison, Clinical Professor in Neuroimaging, School of Medicine, School of Psychology, Cardiff University.

Project ends December 2022