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Quetiapine Monotherapy Controls Bipolar II Depression: Presented at ECNP

By Paula Moyer

AMSTERDAM, THE NETHERLANDS -- October 26, 2005 -- Patients with bipolar II depression get sufficient relief from quetiapine (Seroquel) that no further antidepressant is required, according to findings presented here at the 18^th Congress of the European College of Neuropsychopharmacology (ECNP).

"Quetiapine monotherapy appears to be particularly efficacious for patients with bipolar II depression who have the rapid cycling subtype," according to principal investigator Patricia Suppes, MD, PhD, associate professor of psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.

This is particularly good news because of the risk of rapid cycling with conventional antidepressants, she noted during her presentation on October 24^th.

To determine the efficacy and tolerability of quetiapine monotherapy in patients with bipolar II depression, Dr. Suppes and colleagues conducted a subgroup analysis of a trial that evaluated the drug in patient with bipolar I and bipolar II depression.

They identified subjects who had moderate to severe depression as defined by a Hamilton-D version 17 (HAM-D-17) score of at least 20, a score of at least 2 on HAM-D item 1 pertaining to depressed mood, and a Young Mania Rating Scale (YMRS) score of 12 or less. Patients received 8 weeks of treatment in double-blind fashion with either a fixed dose of quetiapine 600 mg or 300 mg per day or placebo.

Of the 181 patients with bipolar II disorder, 108 (60%) completed the study. When the investigators analyzed the data among the intent-to-treat (ITT) population, they included all 60 of those who were originally on 600 mg of quetiapine, all 59 of those originally on 300 mg of quetiapine, and all 62 of those on placebo.

Results show that subjects in the 2 quetiapine groups had a significantly greater improvement in mean Montgomery Asberg Depression Rating Scale (MADRS) score at week 7 compared with those placebo, with an average MADRS score reduction of 17.2 in the 600-mg group and 16.8 in the 300-mg group. The average reduction in the placebo group was 11.3 (P < .01 for each dose vs placebo).

The difference was not significant at week 8 due to an improvement in the placebo group from week 7 to week 8. Dr. Suppes noted, however, that among the 48 patients with rapid cycling, there was continued improvement in MADRS score at the end of 8 weeks, with an average score reduction of 22.5 points in the 600-mg group (P < .001) and 18.5 points in the 300-mg group (P < .05), compared with 10.4 points in the placebo group.

For the 133 patients without rapid cycling, there was no difference between quetiapine and placebo. The MADRS score decreased by 15.6 points in the treatment groups and by 15.1 points in the placebo group.

The investigators documented no significant changes in the YMRS score. The average weight change from baseline was a gain of 2 kg in the 600-mg quetiapine group, 1.6 kg in the 300-mg quetiapine group, and 0.1 kg in the placebo group.

Sedation or somnolence occurred at a rate of 55.0% with the 600-mg dose, 64.4% with 300 mg, and 12.9% with placebo. Most common adverse events were dry mouth, dizziness, and fatigue. Among these patients, 31.7% in the 600-mg group withdrew due to adverse events, compared with 22% in the 300-mg group, and 6.5% in placebo group.

The study was funded by AstraZeneca, which manufactures Seroquel.


[Presentation title: Quetiapine for the Treatment of Bipolar II Depression. Abstract P2.069]

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