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      Quetiapine Effective in Bipolar Mania: Presented at CINP

      By Jill Stein

      PARIS, FRANCE -- June 23, 2004-- Quetiapine monotherapy at a target dose of approximately 600 mg/day produces significant, rapid, and sustained improvements in manic symptoms in patients with bipolar disorder, according to data presented here on June 23rd at the XXIV Collegium Internationale Neuro-psychopharmacologicum.

      Terence A. Ketter, MD, Associate Professor and Chief, Bipolar Disorders Clinic, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, and colleagues assessed the efficacy of quetiapine for the management of mania in patients with bipolar disorder using different criteria for clinical remission/euthymia.

      "Although response rates of 50% to 65% are often reported in studies of bipolar mania, response is usually defined as a relative improvement (typically at least 50%) in symptoms," Dr. Ketter noted. "This means that patients classified as responders may remain significantly symptomatic."

      Absolute remission criteria may be a more clinically meaningful goal than response and may correlate more closely with improvements in long- term functioning, he said.

      In mania studies, clinical remission (euthymia) has been defined as the attainment of a total score on the Young Mania Rating Scale (YMRS) of 12 or less. However, patients meeting this cutoff may still exhibit symptoms that impair functioning and quality of life.

      To develop therapies with improved clinical effectiveness, the use of more stringent remission criteria may be may be appropriate, Dr. Ketter said.

      The present study evaluated the effect of quetiapine on remission using more stringent criteria as follows: 1) YMRS total score of 12 or less plus a total score on the Montgomery-Asberg Depression Rating Scale (MADRS) of 10 or less; or 2) YMRS score of 12 or less plus a MADRS score of 8 or less.

      The addition of MADRS criteria was chosen as a measure of clinically effective treatment for bipolar mania that should not worsen or precipitate depressive symptoms.

      Mean YMRS scores at entry were 33.3 and 33.5 in the quetiapine and placebo groups, respectively.

      After 3 weeks, remission/euthymia rates with quetiapine monotherapy versus placebo were as follows: 37.5% versus 23.1% (YMRS 12 or less); 35.6% versus 21.5% (YMRS 12 or less plus MADRS 10 or less; and 35.1% versus 20.0% (YMRS 12 or less plus MADRS 8 or less; P <.01 for all).

      After 3 months, rates of remission/euthymia versus placebo were 65.4% and 35.9%; 60.1% and 30.8%; 58.7% and 29.7%, respectively (P <.001). Of the 37.5% patients in remission/euthymia (YMRS less than or equal to 12) after 3 weeks of quetiapine treatment, 89.7% maintained this status to day 84.

      The average daily dose of quetiapine in responders was 575 mg at day 21 and 598 mg at day 84.

      Patients treated with quetiapine had significantly higher remission rates than those given placebo, regardless of the remission/euthymia criteria used, Dr. Ketter said. Also, remission rates with quetiapine continued to improve over a 12-week period, supporting continued treatment in these patients for ongoing improvement in the symptoms of bipolar mania.

      The study wad funded by AstraZeneca.


      [Presentation title: "Sustained Remission/Euthymia With Quetiapine Monotherapy for Bipolar Mania." Abstract #P02.095]



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