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A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder.
J Clin Psychiatry. 2003 Sep; 64(9):1013-24.JC

Abstract

BACKGROUND

The anticonvulsant lamotrigine was previously shown to be effective for bipolar depression. This study assessed the efficacy and tolerability of lamotrigine and lithium compared with placebo for the prevention of mood episodes in bipolar disorder.

METHOD

During an 8- to 16-week open-label phase, lamotrigine (titrated to 200 mg/day) was added to current therapy for currently or recently depressed DSM-IV-defined bipolar I outpatients (N = 966) and concomitant drugs were gradually withdrawn. Patients stabilized on open-label treatment (N = 463) were then randomly assigned to lamotrigine (50, 200, or 400 mg/day; N = 221), lithium (0.8-1.1 mEq/L; N = 121), or placebo (N = 121) monotherapy for up to 18 months. The primary outcome measure was time from randomization to intervention (addition of pharmacotherapy) for any mood episode (depressive, manic, hypomanic, or mixed). Data were gathered from September 1997 to August 2001.

RESULTS

Time to intervention for any mood episode was statistically superior (p = .029) for both lamotrigine and lithium compared with placebo-median survival times were 200, 170, and 93 days, respectively. Intervention for depression was more frequent than for mania by a factor of nearly 3:1. Lamotrigine was statistically superior to placebo at prolonging the time to intervention for a depressive episode (p = .047). The proportions of patients who were intervention-free for depression at 1 year were lamotrigine 57%, lithium 46%, and placebo 45%. Lithium was statistically superior to placebo at prolonging the time to intervention for a manic or hypomanic episode (p = .026). The proportions of patients who were intervention-free for mania at 1 year were lamotrigine 77%, lithium 86%, and placebo 72%. Headache was the most frequent adverse event for all 3 treatment groups.

CONCLUSION

Lamotrigine and lithium were superior to placebo for the prevention of mood episodes in bipolar I patients, with lamotrigine predominantly effective against depression and lithium predominantly effective against mania.

Authors+Show Affiliations

University Hospitals of Cleveland/Case Western Reserve School of Medicine, Department of Psychiatry, 11400 Euclid Ave., Ste. 200, Cleveland, OH 44106, USA. jrc8@po.cwru.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14628976

Citation

Calabrese, Joseph R., et al. "A Placebo-controlled 18-month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder." The Journal of Clinical Psychiatry, vol. 64, no. 9, 2003, pp. 1013-24.
Calabrese JR, Bowden CL, Sachs G, et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. J Clin Psychiatry. 2003;64(9):1013-24.
Calabrese, J. R., Bowden, C. L., Sachs, G., Yatham, L. N., Behnke, K., Mehtonen, O. P., Montgomery, P., Ascher, J., Paska, W., Earl, N., & DeVeaugh-Geiss, J. (2003). A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. The Journal of Clinical Psychiatry, 64(9), 1013-24.
Calabrese JR, et al. A Placebo-controlled 18-month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder. J Clin Psychiatry. 2003;64(9):1013-24. PubMed PMID: 14628976.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. AU - Calabrese,Joseph R, AU - Bowden,Charles L, AU - Sachs,Gary, AU - Yatham,Lakshmi N, AU - Behnke,Kirsten, AU - Mehtonen,Olli-Pekka, AU - Montgomery,Paul, AU - Ascher,John, AU - Paska,Walter, AU - Earl,Nancy, AU - DeVeaugh-Geiss,Joseph, AU - ,, PY - 2003/11/25/pubmed PY - 2004/2/18/medline PY - 2003/11/25/entrez SP - 1013 EP - 24 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 64 IS - 9 N2 - BACKGROUND: The anticonvulsant lamotrigine was previously shown to be effective for bipolar depression. This study assessed the efficacy and tolerability of lamotrigine and lithium compared with placebo for the prevention of mood episodes in bipolar disorder. METHOD: During an 8- to 16-week open-label phase, lamotrigine (titrated to 200 mg/day) was added to current therapy for currently or recently depressed DSM-IV-defined bipolar I outpatients (N = 966) and concomitant drugs were gradually withdrawn. Patients stabilized on open-label treatment (N = 463) were then randomly assigned to lamotrigine (50, 200, or 400 mg/day; N = 221), lithium (0.8-1.1 mEq/L; N = 121), or placebo (N = 121) monotherapy for up to 18 months. The primary outcome measure was time from randomization to intervention (addition of pharmacotherapy) for any mood episode (depressive, manic, hypomanic, or mixed). Data were gathered from September 1997 to August 2001. RESULTS: Time to intervention for any mood episode was statistically superior (p = .029) for both lamotrigine and lithium compared with placebo-median survival times were 200, 170, and 93 days, respectively. Intervention for depression was more frequent than for mania by a factor of nearly 3:1. Lamotrigine was statistically superior to placebo at prolonging the time to intervention for a depressive episode (p = .047). The proportions of patients who were intervention-free for depression at 1 year were lamotrigine 57%, lithium 46%, and placebo 45%. Lithium was statistically superior to placebo at prolonging the time to intervention for a manic or hypomanic episode (p = .026). The proportions of patients who were intervention-free for mania at 1 year were lamotrigine 77%, lithium 86%, and placebo 72%. Headache was the most frequent adverse event for all 3 treatment groups. CONCLUSION: Lamotrigine and lithium were superior to placebo for the prevention of mood episodes in bipolar I patients, with lamotrigine predominantly effective against depression and lithium predominantly effective against mania. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/14628976/A_placebo_controlled_18_month_trial_of_lamotrigine_and_lithium_maintenance_treatment_in_recently_depressed_patients_with_bipolar_I_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2003/v64n09/v64n0906.aspx DB - PRIME DP - Unbound Medicine ER -