BOLDER II study of quetiapine therapy for bipolar depression

Abstract

Remarkably few randomized, controlled trials have evaluated therapies for the depressed phase of bipolar affective disorder. Two similar, 8-week, placebo-controlled bipolar depression studies (known by the acronyms BOLDER I and BOLDER II) were conducted to evaluate the efficacy and tolerability of the atypical antipsychotic quetiapine (300 and 600 mg/day) as monotherapy for bipolar type I and type II depressive episodes. Results of BOLDER II, summarized herein, replicated the findings of BOLDER I. Both doses of quetiapine were significantly more effective than placebo on primary and secondary measures of depressive symptoms. Remission rates on the Montgomery–Asberg Depression Rating Scale were also significantly greater in both quetiapine dose groups (300 mg: 52%; 600 mg: 52%) compared with placebo (37%). Quetiapine therapy was effective in all subtypes of bipolar depression studied. There were no efficacy differences between the two doses of quetiapine. Common adverse events included dry mouth, sedation, somnolence, dizziness and constipation; tolerability tended to be better in the lower quetiapine dose group. Results of the BOLDER II study confirmed that quetiapine is effective as monotherapy for bipolar depression. The 300 mg/day dose is as effective as the 600 mg/day dose. Additional research is needed to determine the minimum effective dose of quetiapine, as well as the efficacy of quetiapine in combination with antidepressants and for prevention of relapse following successful treatment of bipolar depression.

Keywords: :

• atypical antipsychotic
• bipolar disorder
• depression
• quetiapine

Disclosure

The study summarized in this report was funded by AstraZeneca Pharmaceuticals LP. Michael Thase has received research support from, is a consultant to and is a member of the speaker‘s bureau for AstraZeneca Pharmaceuticals LP.