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<!doctype html> <html lang="en-US"> <head class="azee"> <meta charset="UTF-8">  <meta name="viewport" content="width=device-width, initial-scale=1.0, maximum-scale=1.0, minimum-scale=1.0, user-scalable=no" /> <link rel="profile" href="https://gmpg.org/xfn/11"> <script async src='https://securepubads.g.doubleclick.net/tag/js/gpt.js'></script> <script>var ga_obj = {"post_id":14615,"post_type":"product","terms":["depression"]}</script>  <script>(function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-K8NX5MZ');</script>  <meta name='robots' content='index, follow, max-image-preview:large, max-snippet:-1, max-video-preview:-1' />  <title>A Placebo-Controlled 18-Month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder | Psychiatrist.com</title> <link rel="canonical" href="https://www.psychiatrist.com/jcp/placebo-controlled-month-trial-lamotrigine-lithium/" /> <meta property="og:locale" content="en_US" /> <meta property="og:type" content="article" /> <meta property="og:title" content="A Placebo-Controlled 18-Month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder" /> <meta property="og:description" content="Article Abstract Background: The anticonvulsant lamotrigine was previously shown to be effective for bipolar depression. This study assessed the efficacy and tolerability of lamotrigine and lithium compared with placebo for the prevention of mood episodes in bipolar disorder. Method: During an 8- to 16-week open-label phase, lamotrigine (titrated to 200 mg/day) was added to current therapy for currently or recently depressed DSM-IV-defined bipolar I outpatients (N = 966) and concomitant drugs were gradually withdrawn. Patients stabilized on open-label treatment (N = 463) were then randomly assigned to lamotrigine (50, 200, or 400 mg/day; N = 221), lithium (0.8-1.1 mEq/L; N = 121), or placebo (N = 121) monotherapy for up to 18 months. The primary outcome measure was time from randomization to intervention (addition of pharmacotherapy) for any mood episode (depressive, manic, hypomanic, or mixed). Data were gathered from September 1997 to August 2001. Results: Time to intervention for any mood episode was statistically superior (p = .029) for both lamotrigine and lithium compared with placebo-median survival times were 200, 170, and 93 days, respectively. Intervention for depression was more frequent than for mania by a factor of nearly 3:1. Lamotrigine was statistically superior to placebo at prolonging the time to intervention for a depressive episode (p = .047). The proportions of patients who were intervention-free for depression at 1 year were lamotrigine 57%, lithium 46%, and placebo 45%. Lithium was statistically superior to placebo at prolonging the time to intervention for a manic or hypomanic episode (p = .026). The proportions of patients who were intervention-free for mania at 1 year were lamotrigine 77%, lithium 86%, and placebo 72%. Headache was the most frequent adverse event for all 3 treatment groups. Conclusion: Lamotrigine and lithium were superior to placebo for the prevention of mood episodes in bipolar I patients, with lamotrigine predominantly effective against depression and lithium predominantly effective against mania." /> <meta property="og:url" content="https://www.psychiatrist.com/jcp/placebo-controlled-month-trial-lamotrigine-lithium/" /> <meta property="og:modified_time" content="2021-10-27T15:31:11-05:00" /> <meta property="og:published_time" content="2003-09-15T00:00:00-05:00" /> <meta property="og:site_name" content="Psychiatrist.com" /> <meta property="article:modified_time" content="2021-10-27T20:31:11+00:00" /> <meta name="twitter:card" content="summary_large_image" />  <link rel='dns-prefetch' href='//static.klaviyo.com' /> <link rel='dns-prefetch' href='//code.jquery.com' /> <link rel='dns-prefetch' href='//cdnjs.cloudflare.com' /> <link rel='dns-prefetch' href='//maxcdn.bootstrapcdn.com' /> <link rel='dns-prefetch' href='//js.stripe.com' /> <link rel='dns-prefetch' href='//fonts.googleapis.com' /> <link rel="alternate" type="application/rss+xml" title="Psychiatrist.com » Feed" href="https://www.psychiatrist.com/feed/" /> <link rel="alternate" type="application/rss+xml" title="Psychiatrist.com » Comments Feed" href="https://www.psychiatrist.com/comments/feed/" /> <script> window._wpemojiSettings = {"baseUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/72x72\/","ext":".png","svgUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/svg\/","svgExt":".svg","source":{"concatemoji":"https:\/\/www.psychiatrist.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=6.1"}}; /*! 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By downloading this file, you are agreeing to the publisher’s <a href="https://www.psychiatrist.com/terms-of-use">Terms & Conditions.</a></p><p class="tag">Original Research</p>   <h1 class="article-head">A Placebo-Controlled 18-Month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder</h1>   <div id="article-byline"> <div class="author"> <p><span class="bold"></span> Joseph R. Calabrese, MD; Charles L. Bowden, MD; Gary Sachs, MD; Lakshmi N. Yatham, MBBR,FRCPC, MRCPsych; Kirsten Behnke, MD; Olli-Pekka Mehtonen, MD; Paul Montgomery, PharmD; John Ascher,MD; Walter Paska, PhD; Nancy Earl, MD; and Joseph DeVeaugh-Geiss, MD, for the Lamictal 605 Study Group </p> </div> <div id="publish-date"> <p><span class="bold">Published:</span> September 15, 2003</p> </div> </div>  <div id="articlecontent" class="whitelistip abstract"><div class="woocommerce-product-details__short-description"> <div>Article Abstract</div> <div> <p><b><i>Background:</i></b> The anticonvulsant lamotrigine was previously shown to be effective for bipolar depression. This study assessed the efficacy and tolerability of lamotrigine and lithium compared with placebo for the prevention of mood episodes in bipolar disorder.</p> <p><b><i>Method:</i></b> During an 8- to 16-week open-label phase, lamotrigine (titrated to 200 mg/day) was added to current therapy for currently or recently depressed DSM-IV-defined bipolar I outpatients (N = 966) and concomitant drugs were gradually withdrawn. Patients stabilized on open-label treatment (N = 463) were then randomly assigned to lamotrigine (50, 200, or 400 mg/day; N = 221), lithium (0.8-1.1 mEq/L; N = 121), or placebo (N = 121) monotherapy for up to 18 months. The primary outcome measure was time from randomization to intervention (addition of pharmacotherapy) for any mood episode (depressive, manic, hypomanic, or mixed). Data were gathered from September 1997 to August 2001.</p> <p><b><i>Results:</i></b><b> </b>Time to intervention for any mood episode was statistically superior (p = .029) for both lamotrigine and lithium compared with placebo-median survival times were 200, 170, and 93 days, respectively. Intervention for depression was more frequent than for mania by a factor of nearly 3:1. Lamotrigine was statistically superior to placebo at prolonging the time to intervention for a depressive episode (p = .047). The proportions of patients who were intervention-free for depression at 1 year were lamotrigine 57%, lithium 46%, and placebo 45%. Lithium was statistically superior to placebo at prolonging the time to intervention for a manic or hypomanic episode (p = .026). The proportions of patients who were intervention-free for mania at 1 year were lamotrigine 77%, lithium 86%, and placebo 72%. Headache was the most frequent adverse event for all 3 treatment groups.</p> <p><b><i>Conclusion:</i></b><b> </b>Lamotrigine and lithium were superior to placebo for the prevention of mood episodes in bipolar I patients, with lamotrigine predominantly effective against depression and lithium predominantly effective against mania.</p> </div> </div> </div>  <div class="for_mobile"><div class="gad-square"> <div id="ad-Ros_Content"> <p class="advertisement">Advertisement</p> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script> googletag.cmd.push(function() { googletag.display('ad-Ros_Content'); }); </script> </div> </div></div>   <input type="hidden" id="journal_type" value="JCP"> <input type="hidden" id="journal_url" value="https://www.psychiatrist.com/jcp/placebo-controlled-month-trial-lamotrigine-lithium/"> <input type="hidden" id="journal_title" value="A Placebo-Controlled 18-Month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder"> <input type="hidden" id="journal_id" value="14615">  <p style="display: none;">Volume: 64 </p> <p>Quick Links: </p>  <div class="trendmd-sec"> <div id="resultshead"></div> <div id="trendmd-suggestions-page"></div> </div>   <div class="widget-area for_desktop"><div class="g-ad-apart boder-x"><div class="gad-square"><div id="ad-Ros_Mid_Content_1"> <script> googletag.cmd.push(function() { googletag.display('ad-Ros_Mid_Content_1'); 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Editor: Dr Andrade’s analysis of the Bacloville trial in a recent Clinical and Practical Psychopharmacology column, in which he concluded that “individualized treatment with high-dose baclofen (30-300 mg/d) may be a useful second-line approach in heavy drinkers” and that “baclofen may be particularly useful in patients with liver disease,” deserves comment.1 First, Andrade failed to recall that the first pivotal trial of baclofen, ALPADIR (NCT01738282; 320 patients, as with Bacloville), was negative (see Braillon et al2). Second, Dr Andrade should have warned readers that Bacloville’s results are most questionable, lacking robustness. Although he cited us,3 he overlooked the evidence we provided indicating that the Bacloville article4 was published without acknowledging major changes to the initial protocol, affecting the primary outcome. Coincidentally (although as skeptics, we do not believe in coincidence), the initial statistical team was changed when data were sold to the French pharmaceutical company applying for the marketing authorization in France. As Ronald H. Coase warned, “If you torture the data long enough, it will confess.” </div> </div> </div> </div>   <div class="modal fade" id="related_articles_modal" tabindex="-1" role="dialog" aria-labelledby="exampleModalCenterTitle" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered" role="document"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title" id="exampleModalLongTitle">Related Articles</h5> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div> <div class="modal-body"> <div id="trendmd-suggestions"></div> </div> <div class="modal-footer"> <button type="button" class="btn btn-secondary" data-dismiss="modal">Close</button> </div> </div> </div> </div> <div class="modal fade" id="toc_articles_modal" tabindex="-1" role="dialog" aria-labelledby="exampleModalCenterTitle" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered" role="document"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title" id="exampleModalLongTitle">Table Of Contents</h5> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div> <div class="modal-body"> <div id="sections"></div> </div> <div class="modal-footer"> <button type="button" class="btn btn-secondary" data-dismiss="modal">Close</button> </div> </div> </div> </div> <div class="wordpress_loader" id="JCP_loader" style="display:none;"></div> <div class="pswp" tabindex="-1" role="dialog" aria-hidden="true"> <div class="pswp__bg"></div> <div class="pswp__scroll-wrap"> <div class="pswp__container"> <div class="pswp__item"></div> <div class="pswp__item"></div> <div class="pswp__item"></div> </div> <div class="pswp__ui pswp__ui--hidden"> <div class="pswp__top-bar"> <div class="pswp__counter"></div> <button class="pswp__button pswp__button--close" aria-label="Close (Esc)"></button> <button class="pswp__button pswp__button--share" aria-label="Share"></button> <button class="pswp__button pswp__button--fs" aria-label="Toggle fullscreen"></button> <button class="pswp__button pswp__button--zoom" aria-label="Zoom in/out"></button> <div class="pswp__preloader"> <div class="pswp__preloader__icn"> <div class="pswp__preloader__cut"> <div class="pswp__preloader__donut"></div> </div> </div> </div> </div> <div class="pswp__share-modal pswp__share-modal--hidden pswp__single-tap"> <div class="pswp__share-tooltip"></div> </div> <button class="pswp__button pswp__button--arrow--left" aria-label="Previous (arrow left)"></button> <button class="pswp__button pswp__button--arrow--right" aria-label="Next (arrow right)"></button> <div class="pswp__caption"> <div class="pswp__caption__center"></div> </div> </div> </div> </div> <script type="text/javascript"> (function () { var c = document.body.className; 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