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Tuesday 19 April 2005

Patients with Acute Bipolar Mania Show Rapid and Significant Improvement with Geodon

By: Bipolar News

Geodon Improved Symptoms Within Two Days, Was Well Tolerated.

Patients with bipolar mania experiencing manic or mixed (simultaneous symptoms of mania and depression) episodes showed significant improvements by day two of treatment with Pfizer Inc's Geodon® (ziprasidone HCl), according to the findings from a multicenter study reported in the August issue of the Journal of Clinical Psychopharmacology. These findings confirm the rapid onset of efficacy and sustained improvement seen in a previous placebo-controlled study of Geodon in acute bipolar mania.

In this study, Geodon was well tolerated. Treatment-related discontinuations due to adverse events were not significantly different for Geodon compared to placebo (5.8 percent vs. 1.5 percent, respectively, p = NS). Importantly, Geodon did not produce clinically significant increases in body weight, cholesterol and triglycerides, which are commonly seen with other atypical agents.

The three-week, double-blind, placebo-controlled study involved patients with acute bipolar mania experiencing manic symptoms (including irritability, restlessness, high energy, and/or euphoria) with 40 percent of patients experiencing a mixed manic episode: simultaneous depressive symptoms (including sadness, crying, sense of worthlessness, loss of energy, loss of pleasure and/or sleep problems).

“A primary goal in treating acute bipolar mania is rapid symptom reduction, and our study shows that Geodon is effective in achieving that,” said lead author Steven Potkin, MD, professor, Department of Psychiatry and Human Behavior, University of California, Irvine. “This is good news for practitioners as well as patients, who need fast and effective treatment options for this complex illness.”

The study was a multicenter, double-blind, placebo-controlled trial involving 23 sites in the United States, Brazil and Mexico. A total of 206 patients experiencing manic or mixed episodes were given 21 days of treatment with either Geodon (beginning at 80 mg/d and flexibly dosed up to 160 mg/d) or placebo. The investigators assessed the patients at baseline and days 2, 4, 7, 14, and 21, or the last day of treatment for patients who discontinued early, using standard tests for bipolar disorder symptoms.

The findings showed that the average improvement, from baseline to the end of the 21-day study, was significantly greater for Geodon compared to placebo on the primary efficacy measure, a test called the Mania Rating Scale (MRS) (-11.1 vs. -5.6 points on this scale, respectively, p < 0.01). In addition, there were significantly more responders, defined as those demonstrating at least a 50 percent improvement (decrease) in MRS scores from the beginning to the end of the study, in the Geodon group than in the placebo group: 46 percent vs. 29 percent (p < 0.05).

Geodon was also associated with significantly greater improvements in other standard assessments, designated as secondary endpoints, including the Clinical Global Impression-Severity (CGI-S) Scale (p < 0.001), Manic Syndrome (p < 0.01) and Behavior and Ideation Subscales (p < 0.001), Positive and Negative Syndrome Scale Total (p < 0.01) and Positive Subscale (p < 0.001), and Global Assessment of Functioning (p < 0.001).

The most common side effects were somnolence, headache, extrapyramidal syndrome and dizziness. There were no significant changes in either group from the beginning to the end of the study in median weight gain, serum triglyceride or serum cholesterol levels.

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