Symbyax™ (combination olanzapine/fluoxetine) reduces symptoms of suicidal ideation in depressed patients with bipolar disorder within the first week of treatment, with patients who have early-onset disease three times as likely to respond to the medication, according to a presentation at the annual meeting of the American Psychiatric Association. The combination formulation is the first and only approved treatment in the US for the depressive phase of bipolar disorder.

The 8-week analysis of 688 people compared combination medication (n=73), olanzapine (n=299), and placebo (n=316) in the treatment of bipolar I depression. Researchers found that suicidal ideation as measured by the Montgomery-Asberg Depression Rating Scale item 10 (MADRS-10) was significantly reduced by the first week of combination treatment compared with patients receiving placebo or olanzapine. The combination of agents significantly improved symptoms of apparent sadness, reported sadness, pessimistic thoughts, and inner tension - four MADRS items correlated to suicidal ideation - within one week compared to placebo. Olanzapine alone is not indicated for bipolar depression.

"These data provide hope to patients whose lives are disrupted by bipolar depression, a devastating and difficult condition to treat that often results in suicide or suicide attempts," said Terence A. Ketter, MD, presenter. "The rapid reduction of symptoms associated with suicidal ideation suggests the potential benefit of Symbyax among bipolar depressed patients, who are at high risk of taking their own lives."

In addition, a statistical analysis performed on acute-phase data from a double-blind, randomized clinical trial comparing combination medication (n=86), olanzapine (n=370,) and placebo (n=377) in patients with bipolar depression found that an early onset of bipolar disorder (prior to age 20 years) tripled the odds of response to combination medication among patients with bipolar depression. Response was defined as a greater than 50 percent decrease in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Early onset was the only independent variable evaluated that was significant for predicting response among patients with bipolar depression.