OxLith
Research type
Research Study
Full title
OxLith: Exploration of the short-term physical and psychological effects of lithium in mood instability
IRAS ID
154386
Contact name
John Geddes
Contact email
Sponsor organisation
Research & Development Department - Oxford University Hospitals NHS Foundation Trust
Eudract number
2014-002699-98
ISRCTN Number
ISRCTN91624955
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A randomised, placebo-controlled trial to characterise the clinical, cognitive, neural and pathophysiological effects of lithium in people with bipolar disorder and current mood instability.
Bipolar disorder affects around 2% of the world population. Symptoms typically start in adolescence/early adulthood and persist throughout life. Bipolar disorder is usually characterised by manic and depressive episodes but recent studies have highlighted the long-term social and functional impairment associated with inter-episode subsyndromal mood instability. Evaluation of current treatments and the development of more effective, safer treatments could greatly improve the lives of people with bipolar disorder.
Lithium is recommended for long-term inter-episode prevention of mania and depression. It is an effective drug which reduces suicidality. However, lithium has a narrow therapeutic range and the adverse effects include changes in renal, thyroid and parathyroid function. Despite having been prescribed for over 5 decades there is little understanding of the mechanism of action of lithium.
Evaluation and development of treatments for mental illnesses have been hampered by the lack of robust measures of effect. New technologies offer ways to identify biomarkers that measure effects and elucidate mechanisms of action. These include electronic rating systems, brain imaging techniques, activity and sleep monitors, hormone level assays and cognitive function tests. OxLith will use these technologies to explore the mechanism of action of lithium.
OxLith will recruit 40 participants into the randomised phase from Oxford Health NHS Foundation Trust over 2 years. Participants will have bipolar disorder with current mood instability and there will be clinical uncertainty about the prescription of lithium. Following a brief pre-randomisation phase, participants will be randomly allocated lithium or placebo for 6-weeks. They will be asked to rate their mood and complete tasks on an iPad daily, to give blood, saliva and cheek swab samples and to undergo two non-invasive scans (using magnetoencephalography and magnetic resonance imaging).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0109
Date of REC Opinion
14 Apr 2015
REC opinion
Further Information Favourable Opinion