The study aimed to evaluate the efficacy and tolerability of quetiapine monotherapy for depressive episodes in bipolar I or II disorder and to confirm the results of BOLDER I. Results showed significant improvement in measures of depressive symptoms in patients taking quetiapine, said investigator Michael Thase, MD, professor of psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

A total of 509 patients with bipolar I or II disorder were randomized to 8 weeks of double-blind treatment with quetiapine 300 mg/day (n = 172) or 600 mg/day (n = 169) or placebo (n = 168). Patients were assessed weekly using the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Rating Scale for Depression (HAM-D), with primary endpoint the reduction in MADRS total score from baseline at week 8. The study completion rate was 59% and did not differ significantly among treatment groups.

Starting at week 1, reduction in mean HAM-D total score was significantly greater with both quetiapine groups than with placebo (P <.001) and improvement continued through the study endpoint. At week 8, 60% of the 300-mg/day group and 58.3% of the 600-mg/day group were classified as responders, compared with 44.7% on placebo (P <.01 and.05, respectively). Remission was achieved for 51.6% of the 300-mg/day group and 52.3% of the 600-mg/day group than with placebo (37.3%) at week 8, (P <.01 and.05, respectively).

Adverse events were generally mild in intensity, with discontinuation rates due to adverse events 8.1% (300 mg/d), 11.2% (600 mg/d), and 1.2% (placebo). Rates of treatment-emergent mania were low and similar to placebo: 1.8% with 300 mg/day, 3.6% with 600 mg/day, and 6.6% with placebo.

"It's a complete replication," of BOLDER I, said Dr. Thase. He added it would be a significant advance to have a single-agent monotherapy to treat the manic and depressive episodes of bipolar disorder, which is usually treated with both a mood stabilizer and an antidepressant.

The study was sponsored by AstraZeneca.


[Presentation title: Efficacy of Quetiapine Monotherapy in Bipolar Depression: A Confirmatory Double-Blind, Placebo-Controlled Study (The BOLDER II Study). Abstract NR 600]

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