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Olanzapine Plus Lithium or Valproate Effective for Bipolar Relapse Prevention: Presented at APA
By Bruce Sylvester
PHILADELPHIA, PA -- May 22, 2002 -- Continued olanzapine treatment appears to significantly delay symptomatic relapse in patients with bipolar disorder who are stabilized with olanzapine and lithium or with valproate, researchers reported at the annual meeting of the American Psychiatric Association (APA).
"For patients, each day spent with manic or depressive symptoms can be devastating," said lead researcher Mauricio F. Tohen, MD, of the department of research, Eli Lilly and Company in Indianapolis. "So maintaining remission over time is vital."
After six weeks of acute therapy, subjects who reached a remission of symptoms on olanzapine combined with lithium or valproate were randomized to olanzapine 5-20 mg/day (30 patients) or placebo (38 patients), concomitant with ongoing valproate (50-125 mg/mL) or lithium (0.6-1.2 mEq/L). Remission was defined as a score of 12 or less on the Young Mania Rating Scale and a score of 8 or less on the Hamilton Depression Rating Scale.
Placebo subjects in remission from symptoms of bipolar disorder at the end of the acute therapy relapsed into mania or depression at a rate of 55.3 percent during the 18-month trial, while olanzapine-treated patients relapsed at a rate of 36.7 percent (p=0.149).
Time to bipolar relapse differed markedly (p=0.023) between the two groups. Twenty-five percent of placebo-treated patients relapsed into mania or depression by day 15; 25 percent of olanzapine-treated patients relapsed into mania or depression by day 124. The researchers noted relapse to mania in 28.9 percent of placebo-treated patients and in 20.0 percent of olanzapine-treated patients (p=0.574). Rates of relapse to depression were 39.5 percent for the placebo group and 23.3 for the olanzapine group (p=0.197).
"Often a mood stabilizer is not enough to adequately control all phases of the illness and maintain remission, so doctors may need to consider appropriate additional medication to stabilize mood," said Paul Keck, MD, professor of medicine at the University of Cincinnati College of Medicine. "These data suggest that olanzapine, when added to lithium or valproate, may help improve the long-term picture."
Funding for this study was provided by Eli Lilly and Company.
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