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Clinical question
Is quetiapine (Seroquel) an effective treatment for adults with bipolar I or
II major depression?
Bottom line
In this short-term study, quetiapine was more effective than placebo in
treating patients with a bipolar I or II disorder experiencing a major
depressive episode. Because of the risk of extrapyramidal side effects,
however, other treatment agents should be considered first.
Reference
Calabrese JR, Keck PE, Macfadden W, et al. A randomized, double-blind,
placebo-controlled trial of quetiapine in the treatment of bipolar I or II
depression. Am J Psychiatry 2005; 162:1351-60.
Study design: Randomized controlled trial (double-blinded)
Setting: Outpatient (specialty)
Synopsis
These investigators randomized (concealed allocation assignment) 542
patients who met DSM-IV criteria for bipolar I or II disorder with a major
depressive episode to 8 weeks of 600 mg or 300 mg quetiapine (Seroquel)
daily, or placebo. Patients blinded to treatment group assignment completed
various scoring systems to measure outcomes. Complete remission was defined
as achieving a score less than or equal to 12 on the Montgomery-Asberg
Depression Rating Scale. Follow-up was complete for 92% of subjects at 8
weeks. Using intention-to-treat analysis, complete remission occurred
significantly more often in patients assigned to a quetiapine group than the
placebo group (53% vs 28%, respectively; number needed to treat = 4; 95% CI,
3 - 6), with no difference between the 2 doses of quetiapine. The overall
rate of study discontinuation due to adverse events (eg, dry mouth,
sedation, dizziness, constipation, headache, nausea, extrapyramidal
symptoms) was 26% in the 600 mg quetiapine group, 16% in the 300 mg group,
and 9% in the placebo group. Treatment-emergent mania was uncommon (3%) and
its incidence did not differ significantly between the quetiapine and
placebo groups. |