Combined Data From Four Large-Scale Studies Demonstrate The Efficacy And Tolerability Of Seroquel In Bipolar Depression

Main Category: Bipolar
Also Included In: Depression;  Mental Health;  Psychology / Psychiatry
Article Date: 25 May 2009 - 2:00 PDT

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Results presented today at the 162nd American Psychiatric Association (APA) congress in San Francisco, CA, demonstrated the efficacy and tolerability of SEROQUEL® (quetiapine fumarate) for treating depressive episodes in bipolar disorder, including the difficult-to-treat bipolar II patient population.1,2 The data are from combined analyses of four large-scale clinical trials to examine SEROQUEL as a treatment for depressive episodes associated with bipolar I and II disorders. SEROQUEL and SEROQUEL XR™, a once-daily, extended-release formulation of SEROQUEL, is one of the most widely studied atypical antipsychotic in bipolar depression and the only agent approved as monotherapy to treat the spectrum of mood episodes associated with bipolar disorder.

"Bipolar disorder is a chronic illness with patients experiencing severe debilitating mood swings. Patients spend a majority of their time ill in the depressed phase of the illness. These important findings confirm that SEROQUEL is an effective agent for the treatment of bipolar depression, and particularly encouraging are the results in bipolar II patients who historically have not responded well to treatment," said Professor Alan Young of the Department of Psychiatry, University of British Columbia, Vancouver, Canada.

Results from a combined analysis of all patients with bipolar I or II disorder (n=2593) demonstrated that SEROQUEL monotherapy was significantly more effective than placebo for treating depressive episodes associated with bipolar disorder as measured by improvements in the Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score (P<0.001 for both doses of SEROQUEL). Similar results were observed in a combined analysis of patients with bipolar II disorder (n=819). In both analyses, improvements were evident as early as week 1 and continued through week 8. The four studies, BOLDER (BipOLar DEpRession) I and II and EMBOLDEN (Efficacy of quetiapine Monotherapy in BipOLar DEpressioN) I and II, had a similarly designed 8-week, randomised, double-blind, placebo-controlled phase to evaluate the efficacy and safety of SEROQUEL monotherapy (fixed dose 300 mg or 600 mg daily) compared with placebo in adult patients with bipolar I or II disorder. The EMBOLDEN studies also included an active comparator arm, lithium in EMBOLDEN I and paroxetine in EMBOLDEN II.

The EMBOLDEN studies also included a 26- to 52-week continuation phase, where patients who achieved remission continued on the same dose of SEROQUEL or were switched to placebo. In the combined analysis of this phase, both doses of SEROQUEL significantly increased the time to recurrence of any mood event (hazard ratio 0.59 [95% CI, 0.41-0.84; P=0.004] for 300 mg/day and 0.45 [95% CI, 0.30-0.67; P<0.001] for 600 mg/day). In the subpopulation of patients with bipolar II disorder, both doses of SEROQUEL significantly reduced the risk of recurrence of any mood event compared with placebo (hazard ratio 0.47 [95% CI, 0.25-0.92; P<0.05] for 300 mg/day and 0.18 [95% CI, 0.07-0.51; P<0.001] for 600 mg/day).

The combined data indicate that SEROQUEL was generally well-tolerated and adverse events were consistent with the known safety profile of quetiapine. The most common adverse events in patients with bipolar disorder were dry mouth, somnolence, sedation, and dizziness. In the subpopulation of patients with bipolar II disorder, the most common adverse events were dry mouth, somnolence, sedation, dizziness, and headache. In the continuation phase of the EMBOLDEN studies, the most common treatment-emergent adverse events with SEROQUEL were headache, somnolence, nasopharyngitis, nausea, diarrhoea, and dry mouth and in the subpopulation of patients with bipolar II disorder were headache, dry mouth, somnolence, nasopharyngitis, dizziness, and nausea.

Similar findings have been observed for SEROQUEL XR, which was approved in the U.S. and Europe in 2008 for the acute treatment of depressive episodes associated with bipolar disorder. In an 8-week study (D144CC00002), SEROQUEL XR 300 mg/day demonstrated significant improvements in MADRS total scores from week 1 though week 8 (both P<0.001) compared with placebo.3

The mechanism of action of SEROQUEL, which involves both antipsychotic and antidepressant activities, may help explain its unique efficacy across the spectrum of mood episodes associated with bipolar disorder. The efficacy of quetiapine in depressive episodes may be partly explained by norepinephrine reuptake inhibition by norquetiapine, the active metabolite of quetiapine.

About SEROQUEL and SEROQUEL XR

Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide. SEROQUEL has been approved in 94 countries for schizophrenia, 92 countries for bipolar mania, in 41 countries for bipolar depression and in 6 countries for bipolar maintenance.

SEROQUEL XR has been approved in 53 countries for schizophrenia, 19 countries for bipolar mania, in 20 countries for bipolar depression, in 9 markets for bipolar maintenance, in 1 market for Major Depressive Disorder (MDD), and in 1 market for Generalised Anxiety Disorder (GAD).

References

1. Calabrese JR, et al. The efficacy of quetiapine monotherapy in bipolar depression: combined data from the BOLDER and EMBOLDEN studies. Presented at the American Psychiatric Association, San Francisco, CA, USA, 16-21 May, 2009.

2. Young AH, et al. The efficacy of quetiapine monotherapy in bipolar II depression: combined data from the BOLDER and EMBOLDEN studies. Presented at the American Psychiatric Association, San Francisco, CA, USA, 16-21 May, 2009.

3. Suppes T, et al. Effectiveness of the new extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression (trial D144CC00002). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008.

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