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Randomised placebo controlled trial of Pramipexole addition to mood stabilisers for treatment resistant bipolar depression

PAX-BD is a new major trial examining a novel treatment for bipolar disorder, funded by the National Institute for Health Research’s (NIHR) Health Technology Assessment (HTA) Board. The study is examining the effectiveness and safety of a drug, pramipexole, which is currently used to treat Parkinson’s Disease, for patients with bipolar disorder who are depressed and have not responded to NICE recommended treatments. The study is being led by Professor Hamish McAllister-Williams from Newcastle University and Northumberland, Tyne and Wear NHS Foundation Trust. Patients will be recruited from across the country.

Bipolar disorder is a serious mental disorder in which suffers experience spells of elevated mood, or mania, in addition to episodes of depression. The disorder can have a profound impact on individuals’ life, relationships, and work. It is one of the leading causes of disability of any health disorder.  Depression tends to be the major burden for patients with bipolar disorder. However, currently treatments for bipolar depression are extremely limited. On average, conventional antidepressants are not effective. 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 has 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 followed up for up to a year. Led from Newcastle, the PAX-BD study brings together collaborators from Glasgow, Nottingham, Oxford, and London.

Recruitment has not yet commenced for PAX-PD, but for more information about the study please see either the plain English summary or the scientific abstract.