Two randomised, double-blind, placebo-controlled studies assessed the efficacy of Quetiapine extended release ( Seroquel XR ) in patients with bipolar disorder: the first ( Study 002 ) examined acute depressive symptoms in patients with bipolar I or bipolar II disorder, while the other ( Study 004 ) examined acute manic symptoms in patients with bipolar I disorder.
The data demonstrated that patients suffering from either bipolar depression or bipolar mania treated with once-daily Quetiapine monotherapy experienced significant symptom reduction as early as the first week of treatment, compared to placebo, and that significant reductions were maintained for the duration of both studies.
Study 002 enrolled 280 acutely depressed adult patients with either bipolar I or II disorder.
In patients receiving Quetiapine extended release 300 mg once daily, MADRS ( Montgomery-Asberg Depression Rating Scale ) score was significantly reduced from baseline after eight weeks of treatment compared with placebo ( -17.4 vs. -11.9, P<0.001 ).
The reduction in MADRS was significant compared to placebo at week 1.
Study 004 enrolled 316 adult bipolar I patients who were currently experiencing a manic or mixed episode.
In patients randomised to Quetiapine extended release once daily ( 300 mg on day 1, followed by 600 mg on day 2 and flexible dosing between 400 and 800 mg for the remainder of the three week study ), Young Mania Rating Scale ( YMRS ) score was significantly reduced from baseline after three weeks of treatment compared with placebo ( -14.3 vs. -10.5, P<0.001 ).
The reduction in YMRS was significant compared to placebo at day 4.
Treatment with Quetiapine extended release was shown to be generally well tolerated in both acute studies and was consistent with the known safety profile of Quetiapine.
The most common adverse events in both studies were sedation, dry mouth and somnolence.
Bipolar disorder is relatively common with a lifetime prevalence of between 3 and 5% worldwide. Sufferers experience episodes of mania and depression alongside periods of normal mood, with symptoms ranging from trouble concentrating and sleep disturbance to high-risk behaviour and thoughts of suicide.
Source: Eighth International Review of Bipolar Disorder ( IRBD) Conference, 2008
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