NEUROCRINE Study - NBI-1065845 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Study overview
Researchers based at King’s College London are running a research study to test a new antidepressant medication called NBI-1065845. It is being tested as an additional treatment for major depressive disorder (MDD) in people who have not responded well to their current antidepressant medication(s). The researchers are looking for participants.
The main purpose of this study is to see how effective this medication is in reducing depressive symptoms.
What do I get for taking part?
People who take part will receive an inconvenience payment of £145 per in-person visit, up to £870 for those who complete the study. Travel expenses will be reimbursed up to £150 per visit. They will also receive free meals and refreshments during study visits.
Participating in the trial
Recruitment for this study is currently open. You may be eligible to take part if you:
- are over 18 years old,
- have depression,
- are currently taking antidepressant treatment yet still experiencing symptoms.
- can attend visits at King’s College Hospital.
Participants enrolled in this trial will be randomised to receive either the new drug (NBI-1065845) or a placebo.
This study will last for 12 -14 weeks and you will be asked to attend 5 study centre visits in south London and 3 virtual visits (conducted through a phone or video call).
During these visits:
- We will be performing tests to check your health throughout the study such as physical exams, electrocardiogram (ECG) testing, and blood and urine tests;
- You will need to take the medication daily;
- and you will be asked to complete questionnaires and interviews about your symptoms.
Some people who express interest may not qualify for the study. Please keep this in mind and continue using any other appropriate treatments or support.
About the new drug and possible effects
NBI-1065845 is a new investigational drug being studied as a potential add on treatment for major depressive disorder. It has already undergone Phase 1 and Phase 2 clinical trials, which have provided some information about its safety, but its overall safety and effectiveness are still being evaluated in this study.
As with any clinical trial, individual responses to the treatment cannot be predicted. Some participants may experience an improvement in symptoms, while others may notice no change or a worsening of symptoms. In addition, all medications have the potential to cause side effects, which participants may experience during the study. These will be discussed with the study doctors prior to participation.
Participants will be monitored closely throughout the study and may withdraw at any time, either at their own request or if the study doctors consider it appropriate.
How do find out more about taking part?
For more information, please contact Lauren Carter, Research Assistant based at the Department of Psychological Medicine at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London.
Email: lauren.carter@kcl.ac.uk
Why take part in research?
Around a million people take part in vital health and care research in the UK every year. Their contributions help others live healthier and better lives, both now and in the future.
There are a variety of different reasons why you may want to take part in research, such as:
- making a difference by helping to improve treatments and quality of life, now and for future generations
- supporting health research for a particular condition or disease that you care about
- access to new treatments
- taking an active role in your own health and care.
