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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Kate E. A. Saunders, Andrea Cipriani, Jennifer Rendell, Mary-Jane Attenburrow, Natalie Nelissen, Amy C. Bilderbeck, Sridhar R. Vasudevan, Grant Churchill, Guy M. Goodwin, Anna C. Nobre, Catherine J. Harmer, Paul J. Harrison, John R. Geddes

Published in: Trials | Issue 1/2016

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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/design

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.

Discussion

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.

Trial registration

ISRCTN91624955. Registered on 22 January 2015.
Literature
1.
Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007;64(5):543–52.CrossRefPubMedPubMedCentral
2.
Miura T, Noma H, Furukawa TA, Mitsuyasu H, Tanaka S, Stockton S, et al. Comparative efficacy and tolerability of pharmacological treatments in the maintenance treatment of bipolar disorder: a systematic review and network meta-analysis. Lancet Psychiatry. 2014;1(5):351–9.CrossRefPubMed
3.
National Institute for Health and Care Excellence. Bipolar disorder: the assessment and management of bipolar disorder in adults, children and young people in primary and secondary care. Clinical guideline 185. London: National Institute for Health and Care Excellence; 2014.
4.
Cipriani A, Hawton K, Stockton S, Geddes JR. Lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis. BMJ. 2013;346:f3646.CrossRefPubMed
5.
McKnight RF, Adida M, Budge K, Stockton S, Goodwin GM, Geddes JR. Lithium toxicity profile: a systematic review and meta-analysis. Lancet. 2012;379(9817):721–8.CrossRefPubMed
6.
Saunders KEA, Goodwin GM. The course of bipolar disorder. Adv Psychiatr Treat. 2010;16:318–28.CrossRef
7.
Bourne C, Aydemir Ö, Balanzá-Martínez V, Bora E, Brissos S, Cavanagh JT, et al. Neuropsychological testing of cognitive impairment in euthymic bipolar disorder: an individual patient data meta-analysis. Acta Psychiatr Scand. 2013;128(3):149–62.CrossRefPubMed
8.
9.
Malhi GS, Geddes JR. Carving bipolarity using a lithium sword. Br J Psychiatry. 2014;205(5):337–9.CrossRefPubMed
10.
BALANCE investigators and collaborators, Geddes JR, Goodwin GM, Rendell J, Azorin JM, Cipriani A, et al. Lithium plus valproate combination therapy versus monotherapy for relapse prevention in bipolar I disorder (BALANCE): a randomised open-label trial. Lancet. 2010;375(9712):385–95.CrossRef
11.
12.
Judd LL, Akiskal HS, Schettler PJ, Coryell W, Endicott J, Maser JD, et al. A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder. Arch Gen Psychiatry. 2003;60(3):261–9.CrossRefPubMed
13.
Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002;59(6):530–7.CrossRefPubMed
14.
Howes OD, Lim S, Theologos G, Yung AR, Goodwin GM, McGuire P. A comprehensive review and model of putative prodromal features of bipolar affective disorder. Psychol Med. 2011;41(8):1567–77.CrossRefPubMedPubMedCentral
15.
Bopp JM, Miklowitz DJ, Goodwin GM, Stevens W, Rendell JM, Geddes JR. The longitudinal course of bipolar disorder as revealed through weekly text messaging: a feasibility study. Bipolar Disord. 2010;12(3):327–34.CrossRefPubMedPubMedCentral
16.
Benazzi F. Characteristics of bipolar II patients with interpersonal rejection sensitivity. Psychiatry Clin Neurosci. 2000;54(4):499–501.CrossRefPubMed
17.
Bonsall MB, Wallace-Hadrill SM, Geddes JR, Goodwin GM, Holmes EA. Nonlinear time-series approaches in characterizing mood stability and mood instability in bipolar disorder. Proc Biol Sci. 2012;279(1730):916–24.CrossRefPubMedPubMedCentral
18.
19.
MacKinnon DF, Zandi PP, Gershon E, Nurnberger Jr JI, Reich T, DePaulo JR. Rapid switching of mood in families with multiple cases of bipolar disorder. Arch Gen Psychiatry. 2003;60(9):921–8.CrossRefPubMed
20.
Harmer CJ, Goodwin GM, Cowen PJ. Why do antidepressants take so long to work? A cognitive neuropsychological model of antidepressant drug action. Br J Psychiatry. 2009;195(2):102–8.CrossRefPubMed
21.
Lyons T. Differential equations driven by rough signals. Rev Matematica Iberoamericana. 1988;14:215–310.
Metadata
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
Authors
Kate E. A. Saunders
Andrea Cipriani
Jennifer Rendell
Mary-Jane Attenburrow
Natalie Nelissen
Amy C. Bilderbeck
Sridhar R. Vasudevan
Grant Churchill
Guy M. Goodwin
Anna C. Nobre
Catherine J. Harmer
Paul J. Harrison
John R. Geddes
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1230-7

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