MRC-BLISS
Research type
Research Study
Full title
MRC Bipolar Lithium Imaging and Spectroscopy Study (BLISS)
IRAS ID
150168
Contact name
Simon Douglas
Contact email
Sponsor organisation
Northumberland Tyne and Wear NHS Foundation Trust
Clinicaltrials.gov Identifier
7214, NuTH R&D
Research summary
Bipolar disorder is a common psychiatric condition characterised by periods of depression and mania. It is highly recurrent, causing substantial disruption to health, social and occupational status as well as shortening lifespan. Lithium treats and prevents mania and depression whilst reducing suicidal behaviour, but not all patients respond favourably. Clinical assessment is of limited value in predicting response and laboratory measures thus far have proved unfruitful.
Magnetic resonance techniques can demonstrate the effects of lithium on the brain and hold the potential to identify responders or non-responders early in the course of treatment. To date, the value of using advanced scanning techniques to characterise or predict response to lithium has not been thoroughly investigated.
We propose a cross-sectional study exploring the relationship between the clinical effects of lithium and specifically acquired magnetic resonance estimates of its action on the brain, analysed with respect to response. There will be three groups: patients with bipolar disorder taking lithium (n=80); patients with bipolar disorder taking other maintenance medication and naïve to lithium (n=40); healthy comparator volunteers (n=40). Patients will be eligible for enrolment only if they are currently well (euthymic). Subjects choosing to participate will undergo a clinical interview, complete a brief cognitive test battery and provide blood and saliva samples (including sample banking for future anonymised genetic analysis). All subjects will have a magnetic resonance scan lasting one hour; patients taking lithium will have a second scan of similar duration on the same day, its purpose to determine the concentration and distribution of lithium in the brain using techniques novel to Newcastle University. Alterations to treatments are not part of the study protocol.
After completing the cross-sectional study, patients will be invited to enter a long term follow-up arm of the study, returning yearly three times for a clinical interview rating ongoing response to treatment.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1135
Date of REC Opinion
30 Sep 2014
REC opinion
Favourable Opinion