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47 Lithium and Its Role in Psychiatry Roy H 47 Lithium and Its Role in Psychiatry Roy H. Perlis, MD, MSc, and Michael J. Ostacher, MD, MPH, MMSc KEY POINTS formation. This effect is reversed by addition of myoinositol, providing some support for the importance of InsP3 in lithi- • Lithium remains a first-line treatment for all phases um’s effect. In the second, lithium inhibits glycogen synthesis kinase of bipolar disorder, including mania, depression, and 4–7 prevention of recurrence. 3-beta (GSK3B), an important enzyme in pathways includ- ing the Wnt signaling cascade.8 ,Notably mice expressing lower • While not examined in a controlled trial, abundant levels of GSK3B exhibit behaviors similar to mice treated evidence supports a role for lithium in decreasing the chronically with lithium.9 Signaling through the GSK3B risk of suicide. pathway may also be central to the observed neuroprotective 10 • Lithium has a narrow therapeutic window, effects of lithium. ,Of course both InsP3 and GSK3B pathways necessitating careful titration and close monitoring of have convergent effects—both influence the serine/threonine plasma levels. kinase Akt-1,4 for example. Expression of other genes (typi- • Lithium toxicity may cause confusion and ataxia. cally in lymphocytes) has been shown in single studies to be influenced by lithium administration, though the relevance of • Drugs that affect lithium levels include non-steroidal these effects to lithium’s effects on mood or other phenotypes anti-inflammatory drugs (NSAIDs) and diuretics. is unknown. PHARMACOKINETICS AND PHARMACODYNAMICS HISTORICAL CONTEXT Lithium is absorbed through the gut and distributes rapidly The history of lithium’s use in psychiatry parallels the develop- through body water, achieving peak plasma concentrations 1 ment of modern psychopharmacology. The first specific to 2 hours after a single dose. (Slower-release forms may description of the application of lithium to treat mania require 4 to 5 hours to reach peak concentration, because of occurred in 1949, by an Australian named John Cade, who transit time through the gut.) As a monovalent cation like observed that lithium had calming effects on animals and sodium, lithium’s clearance relies entirely on renal function. then treated a series of 10 agitated manic patients. In fact, It is not metabolized by the liver, nor is it significantly protein however, descriptions of lithium treatment date back to at bound while circulating. In general, the half-life for renal least the United States Civil War. An 1883 textbook by Union excretion is approximately 24 hours, so steady-state serum Army Surgeon General William Hammond recommended the levels are typically reached after 5 days. For this reason, lithium use of lithium bromide to treat manic or agitated patients, levels are typically checked about 5 days after initiation or though he later downplayed the importance of lithium. In the dose change. Because lithium distributes throughout the body, early 1900s, a Danish physician, Lange, published a case series it is influenced by lean body mass—for example, among geri- reporting the treatment of manic patients with lithium car- atric patients, lithium levels for a given dose tend to be greater bonate. There is little evidence that lithium was studied than among younger patients with greater lean body (includ- further, however, until Garrod proposed that lithium urate ing muscle) mass. Magnetic resonance spectroscopy studies could be used to treat gout, opening the door to its broader suggest that brain lithium levels are highly correlated with therapeutic application. plasma levels, though less so in patients at the extremes of Unfortunately, despite early studies by Mogen Schou and age—that is, it is possible to have supra-therapeutic levels in others, lithium’s wider adoption in the US was hindered by the central nervous system (CNS) while maintaining a normal concerns about lithium toxicity. Lithium chloride had been plasma lithium level. used as a sodium substitute in the 1940s, until several deaths Drugs that affect renal function, particularly re-absorption, were reported from lithium toxicity among hyponatremic can have profound effects on lithium clearance. Perhaps patients. Thus, lithium was initially perceived as too danger- most notably from a clinical perspective, non-steroidal anti- ous for clinical application, and it was only in 1970 that inflammatory drugs (NSAIDs) or other COX-2 inhibitors may lithium was approved by the United States Food and Drug decrease renal blood flow and thereby increase lithium levels Administration (FDA) for the treatment of mania.1 by up to 25%. Diuretics likewise affect lithium levels, though the nature of their effect depends on their site of action. In the LITHIUM’S MECHANISM OF ACTION kidney, lithium is primarily re-absorbed in the proximal renal tubules, with some subsequent absorption in the loop of The mechanisms by which lithium exerts its therapeutic effects Henle. Importantly, in contrast to sodium, no significant are not entirely clear, but the signaling pathways with which absorption occurs in the distal tubules. Therefore, thiazide it interacts are becoming better understood. Two major diuretics, which act distally, will tend to increase lithium levels pathways are influenced by lithium. In the first, re-cycling of by up to 50%, while those that act more proximally generally inositol is inhibited by lithium, which influences inositol have less of an effect on lithium levels. 2–4 1,4,5-triphosphate (InsP3)-dependent signaling. InsP3 sign- More broadly, hydration status can affect lithium levels: aling acts in part by regulating intra-cellular calcium release individuals who become salt-avid (e.g., because of hypovo- and protein kinase activation, with broad effects. At a neuro- lemia or hyponatremia, perhaps in the context of vomiting nal level, lithium, like valproate, has been shown to increase and diarrhea or self-induced injury, such as long-distance- the spread of growth cones, which are necessary for synapse running) will cause their lithium levels to increase. 525 Downloaded for Rohul Amin ([email protected]) at Uniformed Services Univ of the Health Sciences from ClinicalKey.com by Elsevier on September 21, 2018. For personal use only. No other uses without permission. Copyright ©2018. Elsevier Inc. All rights reserved. 526 PART X Treatment Approaches EVIDENCE FOR LITHIUM’S EFFICACY While these trials showed a positive benefit for lithium, none was a randomized, parallel-group study; instead, they used a Lithium in Acute Mania within-subject design in which each subject was started on Beginning with Schou’s study of lithium versus placebo for lithium or placebo and then switched to the other. It is acute mania, lithium has repeatedly shown efficacy for the unlikely, unfortunately, that there will be any large, well- treatment of mania,11 with the first large randomized study of designed trials of lithium to answer this question, most promi- lithium treatment of acute mania finding lithium comparably nently because there is no pharmaceutical manufacturer effective to the antipsychotic chlorpromazine.12 Since then, producing lithium that has any financial incentive to under- multiple studies have found lithium to be superior to placebo take such a study. and comparable or superior to other agents in the acute man- Lithium, used as monotherapy, appears to be as effective agement of bipolar mania; few studies have found superiority for the treatment of bipolar depression as the combination of for other drugs over lithium. A systematic review found 12 lithium and an antidepressant. In a study comparing imi- acute mania trials comparing lithium to placebo or another pramine, paroxetine, and placebo added to lithium carbonate agent that met their criteria for data-pooling. This review of for the treatment of a major depressive episode in bipolar disorder, neither antidepressant added benefit beyond lithium studies of lithium for acute mania found superiority for 20 lithium over placebo and chlorpromazine, with equivalence alone. Response rates (defined as a Hamilton Depression to valproate and carbamazepine.13 Rating Scale [HAM-D] score of 7 or lower) were 35% for As pointed out by Grunze,14 however, few studies of lithium lithium alone, compared to 39% for imipramine, and 46% in acute mania were undertaken with the methodological for paroxetine. In a secondary analysis, subjects with lower rigor required today for regulatory approval of a drug’s use. By lithium levels (less than 0.8 mEq/L) had a lower response coincidence, the first rigorously designed study to demonstrate rate compared to the adjunctive antidepressant group, suggest- the efficacy of lithium for acute mania was Bowden’s seminal ing, perhaps, that higher lithium levels are as effective as study of divalproex sodium for the treatment of acute mania lithium plus an antidepressant in the treatment of bipolar in 1994, which was designed to study that drug for FDA depression. approval;y b including lithium as an active comparator, the study also demonstrated lithium’s efficacy.15 This study was Lithium for Maintenance Treatment and Relapse adequately powered (i.e., it included a large enough sample Prevention of Bipolar Disorder of patients to find a high probability of finding a statistically significant difference between treatments with a low probabil- Lithium is the archetypal maintenance treatment for bipolar ity of error), compared a drug to an agent known to be effec- disorder. From Prien’s first maintenance study of lithium tive (lithium),
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