New Data Presented For SEROQUEL XRTM In Major Depressive Disorder And Generalised Anxiety Disorder

Two studies presented today at the 8th International Forum on Mood and Anxiety Disorders (IFMAD) in Vienna demonstrated that once-daily SEROQUEL XRTM (quetiapine fumarate extended release tablets) provided significant symptom relief for elderly patients (>65 years of age) with major depressive disorder (MDD) and generalised anxiety disorder (GAD). In both 9-week monotherapy studies - one in MDD (Sapphire)1 and the other in GAD (Chromium)2 - symptoms had improved significantly within one week of quetiapine XR treatment. Further new quetiapine XR data presented at IFMAD included an analysis of patients with anxious depression3 and results from the Amber study4 in MDD.



"Major depressive disorder and generalised anxiety disorder are two closely related conditions that can be difficult to treat, particularly in elderly people," said Professor Stuart Montgomery, Imperial College School of Medicine, London. "In these two studies with elderly patients, quetiapine XR worked quickly to relieve depression and anxiety symptoms within a week, and symptoms continued to improve until the end of the studies. These results are consistent with the positive results previously reported from other studies conducted with quetiapine XR in MDD and GAD in non-elderly adults."



The Sapphire (Study 14) and Chromium (Study 15) studies were double-blind, placebo-controlled trials that randomised elderly patients to receive flexible dose quetiapine XR monotherapy (50-300 mg/day) or placebo. The Sapphire study included 388 elderly MDD patients with a mean age of 71.3 years. After 9 weeks of treatment with quetiapine XR (mean dose 159.9 mg/day), Montgomery-?…sberg Depression Rating Scale (MADRS) total scores were significantly reduced compared with placebo (-16.33 vs. -8.79; P


Safety and tolerability findings were consistent with the known safety profile of quetiapine. The most common adverse events with quetiapine XR were somnolence, dry mouth, dizziness, and headache.




Other quetiapine XR studies presented at IFMAD include a subgroup analysis of pooled results from two similar randomised, double-blind, placebo-controlled trials (studies 1 and 25,6) examining 788 adults defined as having MDD and high levels of anxiety (anxious depression) at entry to the studies.3 Anxious depression has been reported to be associated with poor rates of remission and response to antidepressants compared with nonanxious depression.7 In patients with anxious depression, quetiapine XR monotherapy significantly reduced MADRS total scores at study end for both 150 mg (-14.8; P