What is the study about?
Those with a diagnosis of bipolar disorder tend to have symptoms around 50% of the time, the most frequent symptom is depression. Most of these individuals would be treated with anti-psychotics and anti-depressants, however, there is limited evidence that this is effective in treating the depressive symptoms.
PAX-BD is trialing whether Pramipexole is an effective medication to treat depressive symptoms in those who have bipolar disorder. Pramipexole is a medication which is used to treat Parkinsons and restless leg syndrome, however, it has been seen to have positive effects on mood as well.
Who can take part?
We are looking for people aged 18+ who are under the care of mental health services and have a diagnosis of bipolar disorder and are currently low in mood. We are looking for people who have tried at least 2 of the following medications: lamotrigine, lurasidone, quetiapine, olanzapine.
What is involved?
The study lasts for approximately 1 year. This is split into a screening period of 4 weeks, a 52 week treatment phase and a 2 week follow up.
You will be assigned to either receive Pramipexole or a placebo (you will not know which group you are in). The study drug will be delivered to your home address and you will take this each day and receive regular telephone calls from
Research Assistants who will be checking in on your mood and your symptoms. You will be asked to make occasional visits over the course of the study period to our Abraham Cowley Unit based on the St Peter's Hospital site in Chertsey. We will carry out physical examinations, such as taking your blood pressure and pulse.
How do I get involved?
We would really like to hear from you if you fit the description above and are interested in taking part to help in the search for effective treatment for depression in those with bipolar disorder. Please email us on research@sabp.nhs.uk or call us on 01372 216584.