Randomised placebo controlled trial of Pramipexole in addition to mood stabilisers for treatment resistant bipolar depression (PAX-BD)

PAX-BD is a 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 being led from Newcastle, but patients will be recruited from other sites across the country, including Glasgow, Nottingham, Oxford, and London.

Over a lifetime, 2.5% of people will suffer from bipolar disorder. Sufferers can have great difficulty in leading a normal life and BD is associated with a 10 year reduction in life expectancy. NICE recommends ‘mood stabiliser’ treatments, such as lithium and valproate, to make episodes of elevated and depressed mood less likely. If, despite such treatment, depression occurs, a second (additional) medication is recommended: quetiapine, olanzapine, or lamotrigine. Unfortunately, bipolar depression often does not respond to these treatments and many of these drugs have side effects, including sedation and weight gain. Pramipexole is currently used as a treatment for Parkinson’s disease and its safety and side effects are well known. Two studies suggest that it helps to treat bipolar depression but these studies were small and only lasted 6 weeks.

The aim of PAX-PD is to determine whether pramipexole, added on to mood stabilisers, is a cost effective treatment for patients with bipolar disorder whose depression has not responded to NICE recommended treatment. We will examine this drug compared to placebo (dummy tablets) over 12 months.

Who can take part?

Participants need to have a diagnosis of Bipolar (I or II), be currently depressed and be under the care of Secondary Care Mental Health Services. Participants can be referred to the study via their clinical team.

For more information and a list of inclusion and exclusion criteria please refer to the study website at www.PAXBD.org.

To view a video on the PAX BD study from our recent CPD event, click here.