Source: Am J Med Genet  |  Posted 7 years ago

By Louise Gagnon

MONTREAL, QUEBEC -- October 20, 2004 -- Quetiapine alone is effective in treating bipolar depression, according to research presented here at the 54[^]th[] Canadian Psychiatric Association Annual Meeting.

"The standard therapy is both an antidepressant and a mood stabilizer," said Wayne MacFadden, MD, psychiatrist and US Medical Director, AstraZeneca, Wilmington, Delaware, United States. "This [study] was unique in that it was monotherapy."

In this double-blind, 3-arm study, a total of 170 bipolar subjects were randomised to 8 weeks of treatment with 600 mg quetiapine and 172 bipolar subjects were randomized to 8 weeks of 300mg/day quetiapine. The placebo group comprised 169 individuals.

The subjects taking quetiapine experienced statistically significant improvements in several measurements, including the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating Scale.

"[Quetiapine] demonstrated anti-depressant efficacy and mood-stabilising properties, so that there was a low rate of treatment-emergent mania," stated Dr. McFadden. "Regular antidepressants will push patients into mania/hypomania. The experimental arms had a lower-than-placebo rate of treatment-emergent mania."

Quetiapine monotherapy will likely result in a decrease of adverse events and better compliance, Dr. MacFadden predicted.

"Patients with bipolar disorder typically take 3 or 4 medications, which can make compliance a challenge," Dr. McFadden noted. "If patients have to take just 1 medication, therapy will probably be adhered to."

"We think this may change clinician's practice," added Dr. MacFadden.

Patients in both experimental arms of the study reported twice the adverse events of patients on placebo (e.g., dry mouth, sedation, somnolence, dizziness, and constipation). Withdrawals due to such adverse events were 26.1% in the 600-mg group, 16% in the 300-mg group, and 8.8% in the placebo group.

AztraZeneca sponsored this study.

[Presentation title: "Double-Blind, Placebo-Controlled Study of Quetiapine in Bipolar Depression." Abstract 58]