Table 1 Published and unpublished randomised clinical trials of lamotrigine in bipolar disorder
StudyDiagnosisDesignNoDuration (weeks)ScaleOutcomeResultPublished
SCAA2008ManiaLTG vs Li vs Pla2163MRSLTG −9.3±10.9Failed*No
Li −10.7±11.6
Pla −9.5±10.5
SCAA2009ManiaLTG vs Li vs Pla2296MRSLTG −11.6±14.0Negative†No
Li −15.6±13.0
Pla −11.4±12.3
SCAA2010BipolarLTG vs Pla20610HDRSLTG −10.6±8.3Negative‡No
depressionPla −10.2±8.1
SCA40910BipolarLTG vs Pla2578MADRSLTG −12.2Negative‡No
depressionPla −11.2
SDs not provided
SCAB2001Bipolar depressionLTG vs Pla1957HDRSLTG (200 mg/day) −10.5±8.1 (p = 0.08)Negative‡Yes
LTG (50 mg/day) −9.3±8.9 (p = 0.24)
Pla −7.8±7.9
SCAB2005RapidLTG vs Pla13732TIMEMedian survival timeNegative‡No
cyclingLTG 142 days
Pla 133 days
p = 0.73
SCAA2012RapidLTG vs Pla18234TIMEMedian survival timeNegative‡Yes
cyclingLTG 126 days
Pla 79 days
p = 0.18
SCAB2003ProphylaxisLTG vs Li vs Pla46372TIMEMedian survival timePositiveYes
LTG 200 days
Li 170 days
Pla 93 days
p = 0.029 for both Li and LTG
SCAB2006ProphylaxisLTG vs Li vs Pla17572TIMEMedian survival timePositiveYes
LTG 141 days
Li 292 days
Pla 85 days
p = 0.02 for LTG
p = 0.003 for Li
  • Source for unpublished data: www.gsk.com (accessed 11 June 2009).

  • *Lamotrigine and lithium (active control) were equivalent to placebo, thus no information for or against lamotrigine efficacy can be concluded.

  • †Lamotrigine was equivalent to placebo but lithium was more effective than placebo.

  • ‡Lamotrigine was equivalent to placebo in an adequately powered study to demonstrate modest effect sizes.

  • HDRS, Hamilton Depression Rating Scale; Li, lithium; LTG, lamotrigine; MADRS, Montgomery Asberg Depression Rating Scale; MRS, Mania Rating Scale from SADS-C; Pla, placebo; TIME, time to intervention with psychotropic medications due to full relapse or initiation of relapse into mood episodes.

  • Reprinted with permission from the Medscape Journal of Medicine 2008;10:211. Available at http://www.medscape.com/viewarticle/579046 © 2008 Medscape.