Dec. 14, 2000 According to the largest and only prospective placebo-controlled study in patients with rapid cycling bipolar disorder (manic depression), a drug called lamotrigine is safe and effective in preventing episodes of mood swings. The study, published in the current issue of Journal of Clinical Psychiatry, was authored by Joseph R. Calabrese, MD, Director of the Mood Disorders Center at the University Hospitals of Cleveland, Professor of Psychiatry at the Case Western Reserve University School of Medicine, and the lead researcher.
“There is a clear need for more information in this disease area,” notes Dr. Calabrese. “Patients with rapid-cycling bipolar disorder are constantly moody and difficult to treat. This illness devastates personal relationships, as well as employee/employer relationships. Up until now, there were no medications that were systematically evaluated in large-scale studies.”
Bipolar disorder (also called manic-depressive illness) affects one to two percent of the general population and is characterized by distressing and disruptive mood swings. This disorder usually begins in adolescence or early adulthood, although it can sometimes start in early childhood. Nearly one-fifth of bipolar patients also suffer from rapid-cycling disorder, in which at least four times a year, they experience any combination of manic, hypomanic, mixed or depressive episodes.
In this study, 324 patients who met the criteria for rapid-cycling bipolar disorder were enrolled in an initial stabilization phase, during which lamotrigine was added to the patient’s current treatment. Patients who displayed early signs that their moods were stabilizing were taken off any other medications. If they remained stable on lamotrigine, they were randomized into a new phase of the trial: Some patients received ongoing treatment with lamotrigine; others received a placebo. Of the 177 patients who entered this second phase of the study, 41 percent of the patients who received lamotrigine remained stable without relapse into depression or mania for six months; only 26 percent of the placebo group remained stable for that same period. The greatest degree of effectiveness was observed in those patients with bipolar II disorder (mostly depressions with only mild highs). Of these patients, 46% of patients on lamotrigine were stable without relapse for the entire study as opposed to only 18% on placebo.
In the study, lamotrigine was well-tolerated and the side effects associated with it during the randomized phase were comparable to placebo. Most side effects, including headache, nausea, rash, infection, were mild or moderate, and no significant weight gain was reported. There were no serious side effects and no serious rashes.
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