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Lamotrigine/Lithium Combination Shows Potential for Bipolar I Disorder: Presented at CINP

By Jill Stein

PARIS, FRANCE -- June 22, 2004 -- The combination of lamotrigine and lithium seems to be effective and well tolerated in the management of bipolar I disorder, whether the combination is started after a recent depression or mania/hypomania/mixed episode, suggest results presented here on June 22nd at the XXIV Collegium Internationale Neuro-psychopharmacologicum.

Trisha Suppes, MD, Associate Professor of Psychiatry, University of Texas Southwestern Medical Center, Dallas, and colleagues pooled data from the preliminary phase of 2 large maintenance trials in bipolar I disorder. Overall, 1305 patients had completed an 8- to 16-week open-label phase where lamotrigine was administered as adjunctive or monotherapy.

"Mortality in the depressive phase of bipolar disorder is high, with suicide attempted by as many as 1 in 5 people, typically during a depressed or mixed episode," Dr. Suppes observed. "Current treatment guidelines suggest the use of mood stabilizers to prevent mood episodes."

Two mood stabilizers -- lamotrigine and lithium -- have demonstrated efficacy as maintenance therapy in bipolar disorder, she said. Lamotrigine appears to stabilize mood predominantly at the depressive pole, whereas lithium appears to stabilize mood at the manic pole. Therefore, the combination of these therapies may provide complementary therapeutic profiles and therapeutic synergies, she added.

No drug-drug interactions are known to exist between lithium and lamotrigine, yet few data exist on the combination of these drugs.

In the present analysis, psychiatric rating scale scores and adverse events were examined in 292 patients who received concomitant lamotrigine and lithium therapy. Subjects had a mean co-exposure of 8 weeks.

Mean scores on the Clinical Global Impressions scale for Severity (CGI-S) and Global Assessment Scale (GAS) were 4.4 and 48.7 at enrollment and 2.7 and 66.5 at the end of the preliminary phase.

Incidence of adverse events was similar in patients who had received concomitant therapy and those who had not. The incidence of rash was not significantly increased with combination therapy when recommended dosing strategies were used.

Dr. Suppes said that while the data are encouraging, controlled clinical trials to examine the long-term efficacy and tolerability of lamotrigine and lithium are needed.

Lamotrigine is approved in the United States to delay mood episodes in patients with bipolar I disorder. Funding for the study was provided by GlaxoSmithKline.


[Presentation title: "Concomitant Use of Lamotrigine and Lithium as Maintenance Therapy in Patients With Bipolar I Disorder." Abstract #P01-075]

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