The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
A Placebo-Controlled 18-Month Trial of Lamotrigine and Lithium Maintenance Treatment in Recently Depressed Patients With Bipolar I Disorder
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for currently or recently depressed DSM-IV-defined bipolar I outpatients (N = 966) and concomitant drugs were gradually withdrawn.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.
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Citations
Cites
Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817
Kessler, R. C. (1994) · Archives of General Psychiatry · doi:10.1001/archpsyc.1994.03950010008002 · Cited by 12,370
The Global Assessment Scale: A Procedure for Measuring Overall Severity of Psychiatric Disturbance
Endicott, J. (1976) · Archives of General Psychiatry · doi:10.1001/archpsyc.1976.01770060086012 · Cited by 4,982
The Long-term Natural History of the Weekly Symptomatic Status of Bipolar I Disorder
Judd, L. L., Akiskal, H. S., Schettler, P. J., Endicott, J., Maser, J., Solomon, D. A., Leon, A. C., Rice, J. A., & Keller, M. B. (2002) · Archives of General Psychiatry · doi:10.1001/archpsyc.59.6.530 · Cited by 2,106
Bowden, C. L. (2000) · Archives of General Psychiatry · doi:10.1001/archpsyc.57.5.481 · Cited by 678
Self-citationCalabrese, 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., et al. (2000) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v61n1106 · Cited by 498
Self-citationPrien, R. F. (1973) · Archives of General Psychiatry · doi:10.1001/archpsyc.1973.04200030104017 · Cited by 448
A Placebo-Controlled Study of Lamotrigine and Gabapentin Monotherapy in Refractory Mood Disorders
Frye, M. A., Ketter, T. A., Kimbrell, T. A., Dunn, R. T., Speer, A. M., Osuch, E. A., Luckenbaugh, D. A., Corá-Locatelli, G., Leverich, G. S., & Post, R. M. (2000) · Journal of Clinical Psychopharmacology · doi:10.1097/00004714-200012000-00004 · Cited by 446
Cited by
Yatham, L. N., Kennedy, S. H., Parikh, S. V., Schaffer, A., Bond, D. J., Frey, B. N., Sharma, V., Goldstein, B. I., Rej, S., Beaulieu, S., et al. (2018) · Bipolar Disorders · doi:10.1111/bdi.12609 · Cited by 1,852
Self-citationMalhi, G. S., Bassett, D., Boyce, P., Bryant, R., Fitzgerald, P. B., Fritz, K., Hopwood, M., Lyndon, B., Mulder, R., Murray, G., et al. (2015) · Australian & New Zealand Journal of Psychiatry · doi:10.1177/0004867415617657 · Cited by 842
“Lamotrigine has greater efficacy in the prevention of depressive relapse but relatively modest impact on risk of manic relapse (Level I) (Bowden et al., 2003; Calabrese et al., 2003; Goodwin et al., 2004; Licht et al., 2010; Van der Loos et al., 2011).”
BackgroundDecreased risk of suicides and attempts during long‐term lithium treatment: a meta‐analytic review
Baldessarini, R. J., Tondo, L., Davis, P., Pompili, M., Goodwin, F. K., & Hennen, J. (2006) · Bipolar Disorders · doi:10.1111/j.1399-5618.2006.00344.x · Cited by 753
Cipriani, A., Pretty, H., Hawton, K., & Geddes, J. R. (2005) · American Journal of Psychiatry · doi:10.1176/appi.ajp.162.10.1805 · Cited by 617
Thase, M. E., Macfadden, W., Weisler, R. H., Chang, W., Paulsson, B., Khan, A., & Calabrese, J. R. (2006) · Journal of Clinical Psychopharmacology · doi:10.1097/01.jcp.0000248603.76231.b7 · Cited by 559
Self-citation
Metadata
- Authors
- 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., & Lamictal 605 Study Group
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2003-09-15
- Volume
- 64
- Issue
- 9
- Pages
- 1013-1024
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2084399232
- Cited by
- 635
- References
- 8
- FWCI
- 33.09
- Type
- journal article
- Language
- en
- Open access
- closed
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- 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., & Lamictal 605 Study Group. (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. https://doi.org/10.4088/jcp.v64n0906
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
