title: Oxford Lithium Trial (OxLith) of the early affective, cognitive, neural and biochemical effects of lithium carbonate in bipolar disorder: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Despite lithium's being the most effective drug for bipolar disorder and in clinical use for decades, we still know very little about its early effects relevant to its mode of action.
  
  
  METHODS
  The Oxford Lithium Trial is a double-blind, randomised, placebo-controlled study of 6-week lithium treatment in participants with bipolar disorder and mood instability. Its aim is to identify early clinical, neurocognitive and biological effects. Participants (n = 40) will undergo an intensive battery of multi-modal investigations, including remote monitoring of mood, activity and physiology, as well as cognitive testing, fMRI and magnetoencephalography, together with biochemical and gene expression measurements to assess renal, inflammatory and circadian effects.
  
  
  CONCLUSIONS
  The findings derived from this trial may be of value in predicting subsequent therapeutic response or side effects, not only relevant to the use of lithium but also providing a potential signature to help in more rapid evaluation of novel mood stabilisers. In this respect, OxLith is a step towards the development of a valid experimental medicine model for bipolar disorder.
  
  
  BACKGROUND
  ISRCTN91624955 . Registered on 22 January 2015.
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. kate.saunders@psych.ox.ac.uk.
authors.forename: Kate E A
authors.initials: KE
authors.lastname: Saunders
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. andrea.cipriani@psych.ox.ac.uk.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cipriani
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. jennifer.rendell@psych.ox.ac.uk.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rendell
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. mary-jane.attenburrow@psych.ox.ac.uk.
authors.forename: Mary-Jane
authors.initials: MJ
authors.lastname: Attenburrow
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. natalie.nelissen@psych.ox.ac.uk.
authors.forename: Natalie
authors.initials: N
authors.lastname: Nelissen
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. amy.bilderbeck@psych.ox.ac.uk.
authors.forename: Amy C
authors.initials: AC
authors.lastname: Bilderbeck
authors.affiliation: Department of Pharmacology, Oxford University, Mansfield Road, Oxford, OX1 3QT, United Kingdom. sridhar.vasudevan@psych.ox.ac.uk.
authors.forename: Sridhar R
authors.initials: SR
authors.lastname: Vasudevan
authors.affiliation: Department of Pharmacology, Oxford University, Mansfield Road, Oxford, OX1 3QT, United Kingdom. grant.churchill@psych.ox.ac.uk.
authors.forename: Grant
authors.initials: G
authors.lastname: Churchill
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. guy.goodwin@psych.ox.ac.uk.
authors.forename: Guy M
authors.initials: GM
authors.lastname: Goodwin
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. kia.nobre@psy.ox.ac.uk.
authors.forename: Anna C
authors.initials: AC
authors.lastname: Nobre
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. catherine.harmer@psych.ox.ac.uk.
authors.forename: Catherine J
authors.initials: CJ
authors.lastname: Harmer
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. paul.harrison@psych.ox.ac.uk.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Harrison
authors.affiliation: Department of Psychiatry, Oxford University, Oxford Health NHS Foundation Trust , Warneford Hospital, Oxford, OX3 7JX, United Kingdom. john.geddes@psych.ox.ac.uk.
authors.forename: John R
authors.initials: JR
authors.lastname: Geddes
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects*; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D001921:Brain / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology; D002985:Clinical Protocols; D003071:Cognition / Q000187:drug effects*; D004311:Double-Blind Method; D004739:England; D005260:Female; D005786:Gene Expression Regulation / Q000187:drug effects; D006801:Humans; D016651:Lithium Carbonate / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D015225:Magnetoencephalography; D008297:Male; D009483:Neuropsychological Tests; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018692:Antimanic Agents; D015415:Biomarkers; D016651:Lithium Carbonate