Patients from across the country will be recruited to take part in a major trial examining a new treatment for bipolar disorder.
The study, funded by the National Institute for Health Research’s (NIHR) Health Technology Assessment (HTA) Board, examines the effectiveness and safety of a drug currently used to treat Parkinson’s disease.
The treatment, called pramipexole, will be offered to patients with bipolar disorder who are depressed and have not responded to National Institute for Clinical Excellence (NICE) recommended treatments.
Professor Hamish McAllister-Williams, from Northumberland, Tyne and Wear NHS Foundation Trust (NTW), a local mental health and disability provider, and Newcastle University, is leading the PAX-BD study.
He said: “We are incredibly excited to have secured funding of just short of £2 million to run this important study. It is very important because of the limited number of treatments for bipolar depression that we currently have, many of which cause problematic side effects. Any new treatment option for this very serious condition is to be welcomed.
“The PAX-BD study should provide definitive evidence one way or another whether pramipexole is a safe and effective medication for patients with bipolar depression.
“The study will be run from the NTW Trust with close collaboration with Newcastle University. The goal is recruit patients from around 40 NHS Trusts across the UK.”
Bipolar disorder is a serious mental health disorder in which sufferers experience spells of elevated mood, or mania, in addition to episodes of depression. The disorder can have a profound impact on an individual’s life, relationships and work.
Depression tends to be the major burden for patients with bipolar disorder. However, current treatments for bipolar depression are extremely limited. On average, conventional antidepressants are not effective.
The National Institute for Health and Care Excellence (NICE) lists just three medications that can be effective for bipolar depression, but all can lead to significant side effects and many patients don’t respond to one or more of them. As a result, there is a need for additional alternatives that are both effective and well tolerated. Some preliminary data suggests that pramipexole may be an effective treatment for bipolar depression.
The PAX-BD study aims to compare the safety and effectiveness in 290 patients with bipolar depression that have not responded to at least two NICE recommended treatments. Patients in the study will be treated with either pramipexole or dummy tablets, in addition to ongoing mood stabiliser treatment (such as lithium) and will be followed up for up to a year.
Led from Newcastle, the PAX-BD study brings together collaborators from Glasgow, Nottingham, Oxford, London and Vienna.