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| |  Epilepsy Drug Lamictal Appears Effective For Bipolar Depression RESEARCH TRIANGLE PARK, NC -- March 10, 1999 -- Newly-published data have demonstrated that Lamictal(R) (lamotrigine), an anticonvulsant medication currently used to treat epilepsy, has antidepressant activity in patients with bipolar depression (the depressed phase of bipolar disorder, also known as manic depression). Results from the new study were published in the current issue of Journal of Clinical Psychiatry. This is the first randomised, double-blind, placebo-controlled, multicentre trial to evaluate a single agent as a treatment for the depression component of bipolar disorder. "Typically, patients with bipolar depression are treated with both a mood stabiliser and an antidepressant drug, but additional treatment options are needed," said Joseph Calabrese, M.D., professor of psychiatry at Case Western Reserve University Medical School in Cleveland, and lead author of the study. "Mood stabilisers, such as lithium, are primarily effective in treating the manic phase of bipolar disorder while most antidepressants used to treat the depressive episodes carry the risk of triggering manic episodes or increase the frequency of mania/depression cycles." The article reported that lamotrigine demonstrated evidence of antidepressant activity compared to placebo in the treatment of major depressive episodes in patients with bipolar I disorder and that clinical improvement became evident as early as the third week of treatment. The study was conducted at 15 centres in the U.S. and six centres in the United Kingdom, France and Australia. A total of 195 men and women age 18 and older who were diagnosed with bipolar I disorder and currently experiencing a major depressive episode were randomised to receive lamotrigine or placebo for seven weeks. The dose of lamotrigine was increased gradually to reach the target dose of either 50 or 200 mg/day. Adjunctive use of mood stabilisers such as lithium or valproic acid was not allowed during the study. Baseline psychiatric testing determined that study participants were moderately to markedly ill at the time of enrolment. More than 90 percent had been previously treated for bipolar disorder, more than 50 percent had been hospitalised and over 30 percent had previously attempted suicide. Psychiatric evaluations, including a number of standardised tests, were completed at baseline and at weekly visits. Lamotrigine was generally well tolerated, and serious drug-related adverse events were uncommon. The number of patients who withdrew from the study was comparable between placebo (10), lamotrigine 50 mg (12) and lamotrigine 200 mg (10). The most common adverse event was headache, which was the only event observed significantly more frequently in the groups that received lamotrigine than in the placebo group (35 percent of patients taking lamotrigine 50 mg, 32 percent of patients taking lamotrigine 200 mg, 17 percent of patients taking placebo). Other common adverse events were: nausea (15 percent placebo, 17 percent lamotrigine 50 mg, 16 percent lamotrigine 200 mg); rash (11 percent placebo, 14 percent lamotrigine 50 mg, 11 percent lamotrigine 200 mg); pain (eight percent placebo, eight percent lamotrigine 50 mg, 11 percent lamotrigine 200 mg); and, dizziness (14 percent placebo, nine percent lamotrigine 50 mg, 10 percent lamotrigine 200 mg). Nine clinical trial participants discontinued due to rash, seven out of 129 in the lamotrigine group and two out of 66 in the placebo group, although none of the rashes were considered serious nor did patients require hospitalisation. Serious rashes requiring hospitalisation and discontinuation of treatment have been reported in association with the use of lamotrigine. The incidence of these rashes, which have included Stevens-Johnson Syndrome, is approximately one percent in pediatric patients (age less than 16 years old) and 0.3 percent () in adults. In world-wide post-marketing experience rare cases of toxic epidermal necrolysis and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate. Lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. In the depressed patients enrolled in the bipolar study there was no statistically significant difference in the incidence of hypomanic, manic or mixed episodes between patients receiving lamotrigine (5.4 percent) and placebo (4.6 percent). There were no clinically significant changes in body weight, systolic or diastolic blood pressure, or pulse rate in any of the treatment groups during the course of the trial. Bipolar disorder affects an estimated 2.5 million people in the United States. Onset can occur at any age but is most common in the late teenage years and early 20's. The disorder is characterised by a combination of manic and depressive episodes, sometimes lasting a week or longer each and often with long periods of normal mood in between. The severity and sequence of each episode varies from person to person. Although bipolar disorder is believed to be associated with an imbalance of neurotransmitters in the brain, its exact cause is unknown. Misdiagnosis and delayed treatment are common. People with bipolar disorder are more likely to seek medical help for depressive episodes than for the manic phase. If left untreated, bipolar disorder tends to worsen, with the severity of episodes of mania and/or depression increasing. The suicide rate for untreated bipolar disorder is 15 percent-20 percent. Related Links: Lamictal
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