Seroquel: New Data Shows Efficacy in Bipolar Depression from Week 1

Main Category: Bipolar
Article Date: 24 May 2005 - 18:00 PDT

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New data presented today at the American Psychiatric Association Annual Meeting show that Seroquel (quetiapine) 600mg/day significantly improves depression ratings* including a significant reduction in suicidal thoughts as early as Week 11. The findings also demonstrated that Seroquel improved quality of life2 and adherence to treatment3.

Seroquel is not licensed for bipolar depression. Seroquel is currently licensed for the treatment of manic episodes associated with bipolar disorder and for the treatment of schizophrenia.4

The BOLDER (BipOLar DepRession) study is an eight-week, multi-centered, randomised, double-blind, placebo-controlled study involving 542 patients with a diagnosis of bipolar I or bipolar II disorder. Seroquel demonstrated efficacy in the treatment of bipolar depression, significantly improving core symptoms of depression1 (symptoms include apparent sadness, inability to feel and suicidal thoughts). The trial found that Seroquel is effective in improving quality of life as demonstrated by the improvement in Q-LES-Q SF score**, which was significantly greater in both Seroquel treatment groups2.

"Suicidal thoughts are a common symptom of bipolar disorder and astonishingly 25% to 50% of people with untreated or inadequately treated bipolar disorder attempt suicide", commented Professor Allan Young, Professor of Psychiatry, Royal Victoria Hospital, Newcastle. "These findings are highly relevant to patient care as this is the first time we have seen this level of efficacy in reducing suicidal thinking with an atypical antipsychotic in bipolar disorder. The results show that those treated with Seroquel benefit from a strong efficacy profile, combined with improved compliance and quality of life. The fact that Seroquel is effective in reducing suicidal thoughts within just 1 week and is well tolerated over 8 weeks, should inform clinicians looking to treat their patients both in the here and now and for the future."

Bipolar I disorder is a severe mood disorder where patients swing between states of depression (low mood and energy) and mania (heightened, elevated, ecstatic mood and energy). Bipolar II disorder is a variant whereby patients swing between intense depression and a milder manic state known as 'hypomania'. Patients with both types of bipolar disorder spend significantly longer depressed than manic or hypomanic6, and yet historically the treatment of the depressive phase has not been well studied.7

"There is a major unmet need for effective options for healthcare professionals treating bipolar depression" commented Michelle Rowett, Chief Executive, MDF The Bipolar Organisation. "Antidepressants normally take a number of weeks before they have any effect, and there is also a risk that they may trigger a manic episode. We welcome research into new treatments for bipolar depression, and this data indicates that quetiapine may be a useful addition to treatment options for bipolar depression."

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 $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

In Neuroscience, 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.

* As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Rating Scale for Anxiety (HAM-A)
** The Quality of Life Satisfaction Scale Questionnaire (Q-LES-Q)

Seroquel is a trademark of the AstraZeneca group of companies. Seroquel has been licensed for the treatment of schizophrenia since 1997 and is available in 82 countries for the treatment of this condition. SEROQUEL is also licensed in 63 countries for the treatment of mania associated with bipolar disorder, including the US, Canada and several European countries. To date, over 8 million people have been treated with SEROQUEL worldwide.

Results:

Reducing suicidal thinking key to reducing high suicide rates1:
(As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Rating Scale for Anxiety (HAM-A))

These data, from the BOLDER (BipOLar DEpRession) trial, an eight week, multi-centered, randomised, double-blind, placebo-controlled study involving 542 patients with a diagnosis of bipolar I or II disorder, showed that SEROQUEL (600 and 300 mg/day) is approximately twice as effective in reducing suicidal ideation by week eight as placebo. The results were analysed using standard clinical scales to assess improvements in depressive and anxiety symptoms. Additional results from the BOLDER study showed:

* SEROQUEL (600 and 300 mg/day) significantly improved the core symptoms of depression as early as week one onwards (symptoms include apparent sadness, reported sadness, inability to feel, suicidal thoughts, and pessimistic thoughts)

* A significant improvement in anxiety symptoms occurred as early as week one and was maintained to study end (P<0.001 for both doses).

Improving quality of life and treatment adherence:
(As measured by The Quality of Life Satisfaction scale questionnaire (Q-LES-Q).)

Bipolar depression is also associated with a significant impairment on patients' quality of life. Further new data from the BOLDER trial2 presented at the APA meeting demonstrate a significant improvement in quality of life for patients with bipolar depression who are treated with SEROQUEL (600 and 300 mg/day). Quality of life was measured with a quality of life 16-item questionnaire that measures differences in the degree of enjoyment and satisfaction among groups of patients, as well as changes over time in a single patient. Results showed:

* SEROQUEL is effective in improving quality of life as demonstrated by the improvement in Q-LES-Q SF score which was significantly greater in both SEROQUEL treatment groups (11.7 in the 600 mg/day group and 10.8 in the 300 mg/day group at final assessment) than in the placebo group (6.4, p<0.001)

* Significant improvement in quality of life was noted at the first (Q-LES-Q SF) assessment (week 4)

* SEROQUEL was generally well tolerated, with low levels of extrapyramidal side effects and minimal weight gain.

Treatment adherence data supported:

These data are supported by new results from another trial assessing treatment adherence to antipsychotic monotherapy in bipolar disorder.3 A total of 18,158 antipsychotic monotherapy treatment episodes for bipolar and manic disorders were identified from a claims database. Adherence measures included treatment compliance, captured by regularity of prescription refills, and treatment duration. Atypical antipsychotics included SEROQUEL, risperidone, olanzapine, and ziprasidone; conventional antipsychotic agents included haloperidol, perphenazine, thioridazine, and thiothixene. Results showed:

* SEROQUEL alone had significantly (P<0.05) greater compliance than the conventional agents and had the highest compliance among the atypicals, which was significantly greater than for risperidone or olanzapine

References:

1 MacFadden W. Treatment effects of quetiapine in bipolar depression. Presented at the American Psychiatric Association meeting, May 2005 Atlanta, USA

2 Endicott J, Rajagopalan K, Macfadden W et al. Efficacy of quetiapine in improving quality of life in bipolar depression. Presented at the American Psychiatric Association meeting, May 2005 Atlanta, USA

3 Gianfrancesco FD, Rajagopalan K. Treatment adherence with antipsychotics among bipolar and Manic patients. Presented at the American Psychiatric Association meeting, May 2005. Atlanta USA.

4 Seroquel Summary Product Characteristics. November 2003

6 Judd LL, Akiskal HS, Schettler PJ et al. A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder. Arch Gen Psychiatry 2003;60:261-269

7 Keck PE Jr, Nelson EB, McElroy SL. Advances in the pharmacologic treatment of bipolar depression. Biol Psychiatry 2003;53:671-679

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