Newcastle Clinical Trials Unit



PAX-BD - A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression

Study stage: Closedown/Analysis
Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Funder: NIHR HTA
Therapeutic area: Mental Health
Type of study: CTIMP

Aim: The PAX-BD trial, is a multi-centre, randomised, placebo-controlled trial of pramipexole versus placebo. The aim is to elicit whether pramipexole, co-prescribed with mood stabilising medication (lithium, valproate, carbamazepine, lamotrigine), is an effective treatment for patients with Treatment Resistant Bipolar Depression.

Primary outcome: To evaluate the clinical effectiveness of pramipexole versus placebo alongside standard mood stabilising medication, over 12 weeks, in the management of patients with treatment resistant bipolar depression – collected via the Quick Inventory of DepressivGaste Symptomatology – Self Report (QIDS-SR) at 12 weeks, co-varying for score at 0 weeks.

Population: Adults
Clinical Phase: III
Design: Randomised Control Trial (RCT)
Setting: Secondary Care
Planned Sample Size: 290