Recruitment begins on major research trial for treatment of depression in bipolar disorder

Posted: 15/10/20

Researchers at Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust (CNTW) have begun recruitment to a major trial for treatment for depression in bipolar disorder. After a pause in recruitment the study has been adapted to suit coronavirus restrictions and is now reopening across the country.

The PAX-BD study investigates the safety and effectiveness of pramipexole, a drug used to treat Parkinson’s disease, for which there is some preliminary evidence that it may be effective in treating bipolar depression.

The study, which is funded by the National Institute for Health Research, aims to investigate whether pramipexole is beneficial to people with bipolar disorder who have depression that has not responded to other treatments.

Currently, there are limited treatment options for depression in bipolar disorder and many of these can have significant side effects. Antidepressants are also less likely to work for people who have bipolar depression compared to in people with depression but not bipolar disorder.

Hamish McAllister-Williams, Professor of Affective Disorders at Newcastle University and CNTW, is leading the national study. He said: “Because the treatments for bipolar depression are so limited, a new potential option would be a significant breakthrough.

“This is a really exciting trial for CNTW to be leading on and we’re very proud to be able to continue the Trust’s work as a front-runner in mental health research.”

“Pramipexole is an established drug used by neurologists. It works differently to other currently available treatments for bipolar depression and so it may work for people who have not benefitted from other options.”

Managed by Newcastle Clinical Trials Unit, the study aims to compare the safety and effectiveness of pramipexole with placebo (dummy tablets) in 290 patients that have not responded to at least two NICE recommended treatments.

To be eligible for the study patients need to be aged 18 or over, have bipolar disorder and be currently depressed.
After consenting to the study the study assessments can take place over telephone or video calls. Participants also complete weekly web-based questionnaires to assess their quality of life and mood.

An advisory group of patients and carers has been pivotal in helping to design the study and train the research staff delivering telephone calls to participants.

Simon Douglas, Joint Director or Research, Innovation and Clinical Effectiveness at CNTW, said: “Although CNTW has a long and productive history in mental health research across the UK, we have taken this to the next level with this important national study run in many centres across the UK.

“This experience will enable us to compete with larger and more research-active organisations in the future and to be more successful in research funding bids, resulting in a better service and outcomes for our service users.”