Results from the BOLDER II ( BipOLar DepRession ) study confirm that Quetiapine ( Seroquel ) has the potential as a single medication to treat for major depressive episodes in patients with bipolar disorder.

BOLDER II study was identical in design to BOLDER I. A total of 788 patients were screened, and 509 patients with bipolar I ( n = 338 ) or bipolar II ( n = 171 ) disorder were randomly assigned to receive placebo ( n = 168 ), Quetiapine 300 mg/d ( n = 172 ), or Quetiapine 600 mg/d ( n = 169 ).

The primary end point was change in MADRS total score from baseline to week 8.
Of 509 patients randomized, 59% completed the study.

Improvements from baseline in mean MADRS ( Montgomery-Asberg Depression Rating Scale ) total scores were significantly greater with Quetiapine 300 and 600 mg/d than with placebo from first evaluation ( week 1 ) through week 8.

" Patients treated with Quetiapine in BOLDER II saw an improvement in their depressive symptoms within one week and more than half by week eight," said Michael Thase, at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, and the study's principal investigator.

The exploratory analysis demonstrated significant improvements for Quetiapine recipients in secondary measures, including Hamilton Rating Scales for depression ( HAM-D ) and anxiety ( HAM-A ), and quality of life scores as measured by the Q-LES-Q instrument.

Quetiapine was well tolerated in the study and the few serious adverse events that occurred were not considered related to treatment. Dry mouth, sedation, somnolence and dizziness and constipation were the most common adverse events. Among patients treated with Quetiapine, the incidence of treatment-emergent mania and extra-pyramidal symptoms were low.

Results from BOLDER II confirm earlier findings from BOLDER I, which was published in 2005 and was the first study to report the potential for Quetiapine monotherapy in acute bipolar depression.

Approximately 3–4% of adults worldwide are affected by bipolar disorder, a serious psychiatric condition which was previously known as manic depressive illness.
Bipolar disorder is characterized by recurrent episodes of mania and, more commonly, depression. The disease is chronic and can create considerable problems for patients, spouses and family members if left untreated.

Source: Journal of Clinical Psychopharmacology, 2006


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