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| | | ![]() WCP: Olanzapine-Fluoxetine Better Than Olanzapine Alone For Psychotic Depression By Bruce Sylvester Special to DG News YOKOHAMA, JAPAN -- August 28, 2002 -- Patients treated with olanzapine-fluoxetine combination treatment for psychotic major depression appear to have significantly greater improvement over olanzapine alone or placebo. Researchers presented the findings at the World Conference on Psychiatry here. "This study nicely illustrates that when you use a combination of olanzapine and fluoxetine, you are able to get a synergized effect," said Sanjay Dube, MD, medical director of the Olanzapine-Fluoxetine Combination Team at Lilly Research Laboratories, Indianapolis, Indiana, United States. Researchers compared olanzapine-fluoxetine (OFC) to olanzapine or placebo in two 8-week double-blind trials with a 48-week open-label extension phase. The investigators randomised 249 subjects with psychotic depression into three treatment groups. Efficacy was evaluated with the Hamilton Anxiety and Depression - 24 (HAMD-24) scale. Response rate for the OFC group was significantly greater (56 percent) than for olanzapine (36 percent) or placebo (30 percent). Median time to response for OFC patients was significantly better (12 days) than placebo (20 days), and equal to olanzapine (12 days). In the extension phase, 71 percent of OFC responders maintained their response. Significantly more OFC partial responders (defined as 25 percent total score decrease at two weeks) reached a full endpoint response compared with olanzapine or placebo (64 percent, 35 percent, 32 percent, respectively). At endpoint, there were no significant differences in vital signs between the groups. Mean weight gain for OFC of 2.74 kg was similar to olanzapine at 3.79 (p=0.160) and greater than for placebo at .39 kg. (p=001). There were no statistically significant differences between treatment groups on any scale of extrapyramidal symptoms "With OFC therapy we have a safe combination with a good clinical effect," Dr. Dube added.
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