PAX-BD
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression.
IRAS ID
239794
Contact name
R. Hamish McAllister-Williams
Contact email
Sponsor organisation
Northumberland, Tyne and Wear NHS Foundation Trust
Eudract number
2018-002869-18
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
The PAX-BD trial is a multi-centre, randomised, controlled trial of pramipexole versus placebo, and will elicit whether pramipexole, co-prescribed with a mood stabiliser (lithium, valproate, carbamazepine and/or lamotrigine), is an efficient treatment for treatment resistant bipolar depression.
In a pre-randomisation stage, if participants are on an antipsychotic it will be gradually withdrawn, as it may block the effect of pramipexole. Additionally, if participants are not on a ‘mood stabiliser’, one will be started. Once this is done, 290 participants will be randomly allocated to receive either pramipexole or placebo, in addition to an on-going mood stabiliser. The trial team, participants and their treating mental health team will not know whether the participant receives pramipexole or placebo; the trial is ‘double-blind’. The effectiveness of pramipexole after 12 weeks will be assessed, and participants will continue to be monitored by trial researchers for 48 weeks, even if they discontinue the initial treatment, giving real-life information on the use of this treatment.
The effect on depressive symptoms and quality of life will be assessed, along with side-effects and whether any other treatments are needed. Assessments will be self-reported using an online system completed by participants, who will be supported by email prompts. These methods have worked well in previous studies and participants approve of their use. The system allows more frequent (weekly) self-ratings of bipolar depression symptoms and thus gives a more complete picture of long-term symptom control. Where necessary paper versions will be provided. Participants will be telephoned monthly to assess concomitant medication use and side-effects.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0233
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion