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

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34225686/ (added 07/07/2021)

Registry

who.int

Start Date

August 28, 2019

End Date

March 1, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 29/07/2022:
•Stage 1/ pre\-randomisation:
•1\. Currently under the care of secondary care mental health services at screening with a plan for the patient to remain in secondary care throughout the period of the trial
•2\. A decision made by the patient’s clinical team that a change in medication is indicated
•3\. A current diagnosis of Bipolar Disorder (type I or II), defined as in DSM\-5, which is supported by the use of the Mini\-International Neuropsychiatric Interview (MINI)
•4\. Currently depressed, i.e. meeting DSM\-5 criteria for a Major Depressive Episode assessed via MINI and with a current QIDS\-SR \>10
•5\. Current episode of depression failed to have responded to adequate trials, or lack of tolerability or patient declined/clinically inappropriate, of two different NICE recommended medications (quetiapine, olanzapine (with or without fluoxetine), lamotrigine) or lurasidone. Adequacy of treatment trial defined using a custom\-designed 'Bipolar Demographics and Treatment Questionnaire' (BDTQ).
•6\. Aged 18 years or over at the point of consent
•7\. Willing and able to provide written informed consent prior to any trial procedures taking place
•8\. In the opinion of the investigator, is able to follow the trial prescription instructions and is able to manage 8 weeks supply of trial medication without risk of overdose

•Current exclusion criteria as of 29/07/2022:
•Stage 1/ pre\-randomisation:
•1\. DSM\-5 defined severe substance use disorder.
•2\. Current psychotic symptoms as assessed using the MINI.
•3\. History of retinal disease.
•4\. Current cardiovascular symptoms or significant concerns around cardiovascular disease.
•5\. History of significant renal disease (for example within the last 6 months eGFR is less than 50ml/min/1\.73m2 or there is a concern that eGFR is deteriorating and may be expected to fall below 50 during the course of the study).
•6\. Any known sensitivity to trial drug including its excipients.
•7\. Current pregnancy or planned pregnancy during the trial period, or breastfeeding.
•8\. Starting specific psychotherapy from four weeks before randomisation through to Week 12 post\-randomisation.