American physicians treating depressive episodes associated with bipolar disorder have a new therapeutic option in Symbyax, a combination medication of olanzapine and fluoxetine. The medication is the first to be approved for use in the U.S. specifically for bipolar depression.

"There is a desperate need for an effective treatment for bipolar depression, a devastating condition which often leads patients to take their own lives," said Terence A. Ketter, M.D., Chief of the Bipolar Disorders Clinic, Stanford University School of Medicine.

Patients with bipolar disorder typically spend more than 3 times longer in the depressive phase than in the manic phase of the disorder and take longer to recover from it. In addition, the depressive phase is associated with higher rates of morbidity and mortality. It is estimated that 1 in 4 people with bipolar disorder will attempt suicide at least once, and the relative risk of suicide among patients with bipolar depression has been shown to be nearly 35 times greater than for patients in the manic phase of bipolar disorder.

Approval was based partly on data published in the November issue of the Archives of General Psychiatry. Mauricio Tohen, M.D., Ph.D., and colleagues analyzed the pooled findings from a number of 8-week studies. They found that the combination medication treated symptoms more effectively and at a significantly faster rate than placebo. Patients on active treatment had significantly greater improvement in depressive symptoms at weeks 1, 3, 4, 6, and 8 compared with patients taking placebo. That robust symptom improvement was sustained throughout the entire 8-week study period and was not associated with any increase over placebo in risk for treatment-emergent mania.

The most common adverse event reported in clinical trials was drowsiness. Other common events included weight gain, increased appetite, tremor, sore throat, and difficulty concentrating. Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics, including olanzapine, and concomitant olanzapine and fluoxetine. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes in patients with schizophrenia and the increasing incidence of diabetes in the general population.

Available data are insufficient to provide reliable estimates of differences in hyperglycemia-related adverse-event risk among the marketed atypical antipsychotics. All patients taking an atypical antipsychotic agent, singly or in combination, should be monitored for symptoms of hyperglycemia.

More than 2.5 million Americans live with bipolar disorder, but recent research indicates the real number may be as high as 10 million. The results of untreated bipolar disorder can be catastrophic. An estimated 25 percent of patients with bipolar disorder attempt suicide at least once and approximately 20 percent succeed. This is one of the highest rates for any psychiatric disorder and 3 times higher than that of the general population. The World Health Organization estimates that bipolar disorder is the sixth leading cause of disability in the world.