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Adjunctive treatment for mood stabilization of patients with bipolar I disorder treated with lamotrigine.

Author(s): Spaulding T, Westlund R, Thomason C, White R, Dann R, Thompson T

Affiliation(s): Clinical Development, GlaxoSmithKline, Research Triangle Park, NC 27709, USA. ted.c.spaulding@gsk.com

Publication date & source: 2006-09, CNS Spectr., 11(9):711-6

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To describe the effect of supplemental psychotropic medications, specifically anxiolytics with sedative/hypnotics (ASH) combined with lamotrigine (LTG) on stabilization of symptoms in patients with bipolar I disorder. METHOD: Symptomatic patients participating in two LTG maintenance trials were classified post-hoc as those initiating LTG as monotherapy (n=313) or as adjunctive therapy (n=814) and further characterized by supplemental add-on therapies received during an open-label treatment phase. Patients were considered stabilized if they reached a stable dose of LTG monotherapy (100-200 mg/day) and had a Clinical Global Impressions-Severity scale score <3 for at least 4 weeks. Stabilization rates were compared across initial- and supplemental-treatment groups. RESULTS: Patients who initiated and were maintained on LTG monotherapy were stabilized at a slightly higher rate compared with those taking LTG adjunctive therapy (55% vs 48%; P=.080). Stabilization rates were numerically higher for LTG monotherapy patients who later received only ASH as supplemental medication compared with LTG monotherapy throughout, but this difference was not significant (66% vs 55%; P=.271). Stabilization rates were significantly higher for monotherapy patients who later received ASH alone versus other psychotropic medications (66% vs 28%; P=.001). For patients initiating LTG as adjunctive therapy, adding ASH alone resulted in significantly higher stabilization rates than adding another psychotropic medication (62% vs 33%; P<.001). CONCLUSION: LTG and adjunctive treatment with ASH may be useful in the treatment of acute mood symptoms in patients with bipolar I disorder.

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