First study to show SEROQUEL may be effective in rapid-cycling bipolar disorder

09/24/04

New data shows SEROQUEL works quickly and is well-tolerated in a difficult to treat patient population

Alderley Park, UK - September 24, 2004 - AstraZeneca announced important new data presented today at the 4th European Stanley Foundation Conference on Bipolar Disorder, which show SEROQUEL is significantly more effective than placebo in treating patients with rapid-cycling bipolar disorder and is also well-tolerated in this difficult to treat patient population.1 The results are from the first large-scale, placebo-controlled study of an atypical antipsychotic in the treatment of bipolar I or II depression including patients with rapid-cycling.

Rapid-cycling affects up to one in five people with bipolar disorder and is characterised by the occurrence of four or more episodes of depression, mania or hypomania, cycling within 12 months.2 Patients with rapid-cycling often experience more severe symptoms of depression and are more difficult to treat than non rapid-cycling patients.3

The results show SEROQUEL provided greater effective relief from core symptoms of depression, such as sadness, pessimistic thoughts and suicidal thoughts, than placebo from as early as week one with symptom improvement continuing throughout the 8-week trial. Importantly, this trial also found SEROQUEL was not associated with significant treatment-emergent mania which can occur with other treatments for this condition such as antidepressants.1,2

"Treating depressive episodes in patients who have a rapid-cycling course can be very difficult due to the increased severity and frequency of their symptoms, putting them at greater risk of hospitalisation or suicide," commented Dr. Eduard Vieta, Director of the Bipolar Disorders Program of the Hospital Clinic, University of Barcelona, Spain. "This new data is the first step forward in providing a solution to an urgent medical need and suggests Seroquel could be an important new treatment option for this devastating condition."

The 8-week, double-blind, placebo-controlled study, a subanalysis of patients from a larger SEROQUEL trial known as BOLDER, randomised 108 patients with bipolar I or II disorder exhibiting moderate to severe depression and experiencing a rapid-cycling disease course, to receive SEROQUEL at 300mg/day, SEROQUEL at 600mg/day or placebo. The results of the subanalysis showed patients treated with SEROQUEL experienced:

  • a significantly (p<0.01) greater improvement in mean Montgomery-Asburg Depression Rating Scale (MADRS) score at every assessment from week 1 to week 8 compared with placebo (-17.68, -18.57, -9.87 for SEROQUEL 600mg/day, SEROQUEL 300mg/day and placebo respectively)
  • minimal changes on the Young Mania Rating Scale (YMRS) throughout treatment, with no difference between groups in mean change from baseline to week 8 (+0.1, -1.1, -0.8 for SEROQUEL 600mg/day, SEROQUEL 300mg/day and placebo respectively)
  • treatment-emergent mania was low and similar across each group (two patients for each SEROQUEL arm and one patient on placebo)
  • a low incidence of EPS including akathisia and parkinsonian symptoms and minimal weight change (none of which led to any patient withdrawals).

In addition, new data presented today from the BOLDER trial show that SEROQUEL is effective in reducing the time to treatment response in patients with bipolar depression.4 An 8-week, double-blind, randomised trial involving 542 patients with a diagnosis of bipolar I or bipolar II disorder exhibiting moderate to severe depression found SEROQUEL (300mg/day or 600mg/day) significantly reduces the time taken for patients to respond to their treatment and achieve remission from their symptoms compared to placebo. The results of the trial found that with SEROQUEL:

  • significantly more patients receiving SEROQUEL classified as responders at the final assessment (week 8) compared to placebo (58% vs 36.1%, p<0.001)
  • the median time to response was significantly shorter with SEROQUEL than placebo (p<0.001)
  • significantly more patients met the remission criteria at the final assessment compared to placebo (52.9% vs 28.4%, p<0.001)
  • treatment with SEROQUEL was well-tolerated and not associated with treatment-emergent mania.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world¡¯s leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

In Neuroscienceore, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.

For more information, please visit http://www.astrazenecapressoffice.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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