| Study | Diagnosis | Design | No | Duration (weeks) | Scale | Outcome | Result | Published |
| SCAA2008 | Mania | LTG vs Li vs Pla | 216 | 3 | MRS | LTG −9.3±10.9 | Failed* | No |
| Li −10.7±11.6 | ||||||||
| Pla −9.5±10.5 | ||||||||
| SCAA2009 | Mania | LTG vs Li vs Pla | 229 | 6 | MRS | LTG −11.6±14.0 | Negative† | No |
| Li −15.6±13.0 | ||||||||
| Pla −11.4±12.3 | ||||||||
| SCAA2010 | Bipolar | LTG vs Pla | 206 | 10 | HDRS | LTG −10.6±8.3 | Negative‡ | No |
| depression | Pla −10.2±8.1 | |||||||
| SCA40910 | Bipolar | LTG vs Pla | 257 | 8 | MADRS | LTG −12.2 | Negative‡ | No |
| depression | Pla −11.2 | |||||||
| SDs not provided | ||||||||
| SCAB2001 | Bipolar depression | LTG vs Pla | 195 | 7 | HDRS | LTG (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 | ||||||||
| SCAB2005 | Rapid | LTG vs Pla | 137 | 32 | TIME | Median survival time | Negative‡ | No |
| cycling | LTG 142 days | |||||||
| Pla 133 days | ||||||||
| p = 0.73 | ||||||||
| SCAA2012 | Rapid | LTG vs Pla | 182 | 34 | TIME | Median survival time | Negative‡ | Yes |
| cycling | LTG 126 days | |||||||
| Pla 79 days | ||||||||
| p = 0.18 | ||||||||
| SCAB2003 | Prophylaxis | LTG vs Li vs Pla | 463 | 72 | TIME | Median survival time | Positive | Yes |
| LTG 200 days | ||||||||
| Li 170 days | ||||||||
| Pla 93 days | ||||||||
| p = 0.029 for both Li and LTG | ||||||||
| SCAB2006 | Prophylaxis | LTG vs Li vs Pla | 175 | 72 | TIME | Median survival time | Positive | Yes |
| LTG 141 days | ||||||||
| Li 292 days | ||||||||
| Pla 85 days | ||||||||
| p = 0.02 for LTG | ||||||||
| p = 0.003 for Li |
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Source for unpublished data: www.gsk.com (accessed 11 June 2009).
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*Lamotrigine and lithium (active control) were equivalent to placebo, thus no information for or against lamotrigine efficacy can be concluded.
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†Lamotrigine was equivalent to placebo but lithium was more effective than placebo.
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‡Lamotrigine was equivalent to placebo in an adequately powered study to demonstrate modest effect sizes.
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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.
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Reprinted with permission from the Medscape Journal of Medicine 2008;10:211. Available at http://www.medscape.com/viewarticle/579046 © 2008 Medscape.
