Quetiapine Well-Tolerated, Effective in Bipolar Mania

Laurie Barclay, MD

October 01, 2002

Oct. 2, 2002 — Quetiapine (Seroquel) was effective and well tolerated as adjunctive therapy to mood stabilizers for the treatment of acute bipolar mania, according to the results of a randomized, multicenter, placebo-controlled trial presented last month at the Third European Stanley Foundation Conference on Bipolar Disorder held in Freiburg, Germany.

"The trial results suggest...that not only was Seroquel effective in treating acute mania and the psychotic symptoms often associated with it, but more patients treated with Seroquel experienced a full resolution of their manic symptoms compared to patients taking mood stabilizers alone," lead investigator Gary Sachs, MD, from Harvard Medical School in Boston, Massachusetts, says in a news release.

In this three-week, double-blind trial, 191 patients diagnosed with bipolar I disorder and experiencing a manic episode were titrated to therapeutic levels with mood stabilizers such as lithium or divalproex and were then randomized to additional treatment with quetiapine, mean dose 500 mg per day, or placebo.

The quetiapine group did significantly better than the placebo group in terms of response rate based on Young Mania Rating Scale (YMRS) scores (54.3% vs. 32.6%, P=.003), change from baseline YMRS scores (-13.76 vs. -9.93, P=.021), change in Clinical Global Impressions severity of illness scores (-1.38 vs. -0.78, P=.001), and discontinuation rate including withdrawals for adverse events (38.5% vs. 51.0%).

Adverse events occurring in at least 10% of patients receiving quetiapine were somnolence (40% vs. 10% in the placebo group), headache (27% vs. 21%), dry mouth (19% vs. 4%), asthenia (11% vs. 3%), orthostatic hypotension (11% vs. 3%), and dizziness (10% vs. 6%).

Results from further clinical trials examining the efficacy of quetiapine as both adjunctive and monotherapy for bipolar mania should be announced later this year.

"Current treatment options for patients with acute mania are limited and common therapies such as mood stabilizers are often less effective and associated with troublesome side effects," Sachs says. "Seroquel's impressive efficacy, combined with its superior side effect profile, suggest that it is an important and valuable new resource in our fight against bipolar disorder."

Third European Stanley Foundation Conference on Bipolar Disorder. Sept. 12, 2002.

Reviewed by Gary D. Vogin, MD


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