A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder

J. R. Calabrese, T. Suppes, C. L. Bowden, G. S. Sachs, A. C. Swann, S. L. McElroy, V. Kusumakar, J. A. Ascher, N. L. Earl, P. L. Greene, E. T. Monaghan

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Abstract

Background: Patients with rapid-cycling bipolar disorder are often treatment refractory. This study examined lamotrigine as maintenance monotherapy for rapid-cycling bipolar disorder. Method: Lamotrigine was added to patients' current psychotropic regimens and titrated to clinical effect during an open-label treatment phase. Stabilized patients were tapered off other psychotropics and randomly assigned to lamotrigine or placebo monotherapy for 6 months. Time to additional pharmacotherapy for emerging symptoms was the primary outcome measure. Secondary efficacy measures included survival in study (time to any premature discontinuation), percentage of patients stable without relapse for 6 months, and changes in the Global Assessment Scale and Clinical Global Impressions-Severity scale. Safety was assessed from adverse event, physical examination, and laboratory data. Results: 324 patients with rapid-cycling bipolar disorder (DSM-IV criteria) received open-label lamotrigine, and 182 patients were randomly assigned to the double-blind maintenance phase. The difference between the treatment groups in time to additional pharmacotherapy did not achieve statistical significance in the overall efficacy population. However, survival in study was statistically different between the treatment groups (p = .036). Analyses also indicated a 6-week difference in median survival time favoring lamotrigine. Forty-one percent of lamotrigine patients versus 26% of placebo patients (p = .03) were stable without relapse for 6 months of monotherapy. Lamotrigine was well tolerated; there were no treatment-related changes in laboratory parameters, vital signs, or body weight. No serious rashes occurred. Conclusion: This was the largest and only prospective placebo-controlled study of rapidcycling bipolar disorder patients to date; results indicate Iamotrigine monotherapy is a useful treatment for some patients with rapid-cycling bipolar disorder.

Original languageEnglish (US)
Pages (from-to)841-850
Number of pages10
JournalJournal of Clinical Psychiatry
Volume61
Issue number11
StatePublished - 2000
Externally publishedYes

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Bipolar Disorder
Placebos
Survival
Therapeutics
Maintenance
lamotrigine
Recurrence
Drug Therapy
Vital Signs
Exanthema
Diagnostic and Statistical Manual of Mental Disorders
Physical Examination
Body Weight
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Calabrese, J. R., Suppes, T., Bowden, C. L., Sachs, G. S., Swann, A. C., McElroy, S. L., ... Monaghan, E. T. (2000). A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. Journal of Clinical Psychiatry, 61(11), 841-850.

A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. / Calabrese, J. R.; Suppes, T.; Bowden, C. L.; Sachs, G. S.; Swann, A. C.; McElroy, S. L.; Kusumakar, V.; Ascher, J. A.; Earl, N. L.; Greene, P. L.; Monaghan, E. T.

In: Journal of Clinical Psychiatry, Vol. 61, No. 11, 2000, p. 841-850.

Research output: Contribution to journalArticle

Calabrese, JR, Suppes, T, Bowden, CL, Sachs, GS, Swann, AC, McElroy, SL, Kusumakar, V, Ascher, JA, Earl, NL, Greene, PL & Monaghan, ET 2000, 'A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder', Journal of Clinical Psychiatry, vol. 61, no. 11, pp. 841-850.
Calabrese JR, Suppes T, Bowden CL, Sachs GS, Swann AC, McElroy SL et al. A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. Journal of Clinical Psychiatry. 2000;61(11):841-850.
Calabrese, J. R. ; Suppes, T. ; Bowden, C. L. ; Sachs, G. S. ; Swann, A. C. ; McElroy, S. L. ; Kusumakar, V. ; Ascher, J. A. ; Earl, N. L. ; Greene, P. L. ; Monaghan, E. T. / A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. In: Journal of Clinical Psychiatry. 2000 ; Vol. 61, No. 11. pp. 841-850.
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abstract = "Background: Patients with rapid-cycling bipolar disorder are often treatment refractory. This study examined lamotrigine as maintenance monotherapy for rapid-cycling bipolar disorder. Method: Lamotrigine was added to patients' current psychotropic regimens and titrated to clinical effect during an open-label treatment phase. Stabilized patients were tapered off other psychotropics and randomly assigned to lamotrigine or placebo monotherapy for 6 months. Time to additional pharmacotherapy for emerging symptoms was the primary outcome measure. Secondary efficacy measures included survival in study (time to any premature discontinuation), percentage of patients stable without relapse for 6 months, and changes in the Global Assessment Scale and Clinical Global Impressions-Severity scale. Safety was assessed from adverse event, physical examination, and laboratory data. Results: 324 patients with rapid-cycling bipolar disorder (DSM-IV criteria) received open-label lamotrigine, and 182 patients were randomly assigned to the double-blind maintenance phase. The difference between the treatment groups in time to additional pharmacotherapy did not achieve statistical significance in the overall efficacy population. However, survival in study was statistically different between the treatment groups (p = .036). Analyses also indicated a 6-week difference in median survival time favoring lamotrigine. Forty-one percent of lamotrigine patients versus 26{\%} of placebo patients (p = .03) were stable without relapse for 6 months of monotherapy. Lamotrigine was well tolerated; there were no treatment-related changes in laboratory parameters, vital signs, or body weight. No serious rashes occurred. Conclusion: This was the largest and only prospective placebo-controlled study of rapidcycling bipolar disorder patients to date; results indicate Iamotrigine monotherapy is a useful treatment for some patients with rapid-cycling bipolar disorder.",
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AU - Calabrese, J. R.

AU - Suppes, T.

AU - Bowden, C. L.

AU - Sachs, G. S.

AU - Swann, A. C.

AU - McElroy, S. L.

AU - Kusumakar, V.

AU - Ascher, J. A.

AU - Earl, N. L.

AU - Greene, P. L.

AU - Monaghan, E. T.

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N2 - Background: Patients with rapid-cycling bipolar disorder are often treatment refractory. This study examined lamotrigine as maintenance monotherapy for rapid-cycling bipolar disorder. Method: Lamotrigine was added to patients' current psychotropic regimens and titrated to clinical effect during an open-label treatment phase. Stabilized patients were tapered off other psychotropics and randomly assigned to lamotrigine or placebo monotherapy for 6 months. Time to additional pharmacotherapy for emerging symptoms was the primary outcome measure. Secondary efficacy measures included survival in study (time to any premature discontinuation), percentage of patients stable without relapse for 6 months, and changes in the Global Assessment Scale and Clinical Global Impressions-Severity scale. Safety was assessed from adverse event, physical examination, and laboratory data. Results: 324 patients with rapid-cycling bipolar disorder (DSM-IV criteria) received open-label lamotrigine, and 182 patients were randomly assigned to the double-blind maintenance phase. The difference between the treatment groups in time to additional pharmacotherapy did not achieve statistical significance in the overall efficacy population. However, survival in study was statistically different between the treatment groups (p = .036). Analyses also indicated a 6-week difference in median survival time favoring lamotrigine. Forty-one percent of lamotrigine patients versus 26% of placebo patients (p = .03) were stable without relapse for 6 months of monotherapy. Lamotrigine was well tolerated; there were no treatment-related changes in laboratory parameters, vital signs, or body weight. No serious rashes occurred. Conclusion: This was the largest and only prospective placebo-controlled study of rapidcycling bipolar disorder patients to date; results indicate Iamotrigine monotherapy is a useful treatment for some patients with rapid-cycling bipolar disorder.

AB - Background: Patients with rapid-cycling bipolar disorder are often treatment refractory. This study examined lamotrigine as maintenance monotherapy for rapid-cycling bipolar disorder. Method: Lamotrigine was added to patients' current psychotropic regimens and titrated to clinical effect during an open-label treatment phase. Stabilized patients were tapered off other psychotropics and randomly assigned to lamotrigine or placebo monotherapy for 6 months. Time to additional pharmacotherapy for emerging symptoms was the primary outcome measure. Secondary efficacy measures included survival in study (time to any premature discontinuation), percentage of patients stable without relapse for 6 months, and changes in the Global Assessment Scale and Clinical Global Impressions-Severity scale. Safety was assessed from adverse event, physical examination, and laboratory data. Results: 324 patients with rapid-cycling bipolar disorder (DSM-IV criteria) received open-label lamotrigine, and 182 patients were randomly assigned to the double-blind maintenance phase. The difference between the treatment groups in time to additional pharmacotherapy did not achieve statistical significance in the overall efficacy population. However, survival in study was statistically different between the treatment groups (p = .036). Analyses also indicated a 6-week difference in median survival time favoring lamotrigine. Forty-one percent of lamotrigine patients versus 26% of placebo patients (p = .03) were stable without relapse for 6 months of monotherapy. Lamotrigine was well tolerated; there were no treatment-related changes in laboratory parameters, vital signs, or body weight. No serious rashes occurred. Conclusion: This was the largest and only prospective placebo-controlled study of rapidcycling bipolar disorder patients to date; results indicate Iamotrigine monotherapy is a useful treatment for some patients with rapid-cycling bipolar disorder.

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