Monte Carlo – Nov. 29 – The severity of manic symptoms that plague the victims of bipolar disorder -- which afflicts approximately 1-2 percent of the world population -- was significantly reduced by Topamax® (topiramate) in a multi-centre study of the medication in patients who had a history of poor response or intolerance to mood stabilizers. The study of this potentially new use for Topamax, which is currently approved only for the treatment of various types of epileptic seizures, was presented today at the International Forum on Mood and Anxiety Disorders.
Bipolar disorder is characterized by excessive, disruptive swings in mood, ranging from manic episodes -- marked by extreme agitation, impaired concentration and "racing thoughts" -- to periods of deep depression. Seventy percent of the 61 adults who participated in the 12-week, open-label study experienced an improvement of 50 percent or greater in their scores on the Young Mania Rating Scale -- a widely accepted tool that measures the severity of manic symptoms. In addition, 41 percent met the criteria for remission.
“The data indicate that Topamax may be a promising therapy for the treatment of bipolar disorder, particularly in managing the manic symptoms that can be so destructive episodes,” says Eduard Vieta, MD, who conducted the study and is affiliated with the Bipolar Disorders Programme at the University of Barcelona in Spain. “What makes these positive results so compelling is that the study participants were resistant to or couldn't tolerate conventional mood stabilizers.”
Thirty-nine percent of the study participants took only Topamax to treat their bipolar disorder during the trial. The remainder added Topamax to one or more other mood-stabilizing medications, including lithium (28%), valproate (16%) and carbamazapine (11%). Many of these and other medications used to treat bipolar disorder cause weight gain, often leading to noncompliance. However, none of the patients who took Topamax in this study gained weight, and more than a third (39%) lost weight -- an average of 2-3 kilograms over the three-month period. Weight loss was most pronounced in individuals with the highest body mass index (a measurement of the proportion of fat compared to muscle).
"The weight gain that is so often associated with many conventional bipolar treatments can be significant health problem, and a barrier to treatment compliance," comments Dr. Vieta. "Not only can it contribute or exacerbate other conditions such as cardiovascular disease, it can significantly undermine these individuals' already-low self-esteem."
In the study, participants were given a starting Topamax dose of 79 mg per day and evaluated after 2, 4 and 12 weeks. The dose was titrated up by 20 to 60 mg every 3 to 7 days until maximum clinical response or optimal tolerability was achieved. The average dose at the end of the study was 214 mg per day. The most common side effects (reported by 5-10 percent of patients) included paraesthesia (tingling sensation), somnolence (sleepiness), nausea, abdominal pain, headache, tremor and cognitive disturbance (such as an impaired ability to concentrate). Only one patient, however, dropped out of the study due to side effects.
Bipolar disorder is difficult to diagnose, since the symptoms may be confused with depression or other mood disorders. Without treatment, the disease can be life threatening. Between 25 and 50 percent of those suffering from the condition attempt suicide, and 10-15 percent of those individuals succeed.
This study led by Dr. Vieta supplements the findings of 10 other open-label trials involving more than 275 patients, all of which suggested that Topamax has mood-stabilizing properties. Janssen-Cilag, which partially supported the Vieta study, and its research affiliate -- the R.W. Johnson Pharmaceutical Research Institute -- is currently conducting large-scale Phase III research into the use of Topamax for the treatment of bipolar disorder.
Topamax is marketed under various brand names in more than 75 countries and to date, has been prescribed to approximately 935,000 patients worldwide. Topamax is available in tablets and in capsules that can be opened and sprinkled onto food for easy swallowing. It was discovered and developed by the R.W. Johnson Pharmaceutical Research Institute, and is marketed internationally by Janssen-Cilag, with the exception of Canada (where it is marketed by Janssen-Ortho) and the United States (Ortho-McNeil Pharmaceutical).
For further details please contact:
Vanessa Leon
T: +44 20 7611 3596
Pam Rasmussen Janssen Pharmaceutica
T: +1 609 730 2986