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Quetiapine Extended-Release Effective for Major Depressive Disorder: Presented at APA

By Charlene Laino

WASHINGTON, DC -- May 9, 2008 -- As early as 4 days after the start of treatment, extended-release (ER) quetiapine monotherapy may help to improve symptoms of depression in patients with major depressive disorder, according to results of a randomised, double-blind, placebo-controlled study.

Richard Weisler, MD, Adjunct Professor of Psychiatry, University of North Carolina School of Medicine at Chapel Hill, North Carolina, and Adjunct Assistant Professor, Duke University Medical Center, Durham, North Carolina, presented the findings here at the 161st Annual Meeting of the American Psychiatric Association (APA).

Quetiapine ER is currently indicated for the acute and maintenance treatment of schizophrenia.

For the study, 723 patients were randomised to receive quetiapine ER at a dose of 50, 150, or 300 mg, or placebo, once daily for 6 weeks. A total of 700 patients who received at least 1 dose of the study drug were included in the efficacy analysis.

At baseline, the mean total score on the Montgomery-Asberg Depression Rating Scale (MADRS) was 30.9 points in the 178 patients randomized to 50 mg, 30.9 points in the 168 patients randomized to 150 mg, 30.6 in the 176 patients randomized to 300 mg, and 30.5 in the 178 patients in the placebo arm.

At week 6, the mean MADRS score was reduced significantly in all treatment arms compared with the placebo arm. In the placebo arm, the score decreased by 11.07 points compared with 13.56 points for the 50-mg dose (P < .05), 14.50 points for the 150-mg dose (P < .001), and 14.18 points for the 300-mg dose (P < .01).

The percentage of patients achieving remission as determined by a MADRS score of 8 points or less in the quetiapine arms were 25.8% (P = .08), 20.8% (P = .5), and 26.1% (P = .08), in the 50-, 150-, and 300-mg arms, respectively, and 18.5% in the placebo arm.

Significant improvement was seen in all 3 treatment groups by day 4, when the MADRS scores in each of these group had decreased by 4.91 points (P < .01); 5.43 points (P < .001), and 5.35 points (P < .001), respectively, and by 3.27 points in the placebo arm.

"Typically, we don't see a response until at least 2 weeks and sometimes up to a month after treatment begins. Here we saw a significant improvement in symptoms as early as day 4," Dr. Weisler said.

The most common adverse events associated with the use of quetiapine ER versus placebo included dry mouth, sedation, somnolence, and dizziness. "Clinicians also have to monitor patients for changes in fasting glucose levels, blood lipids, and weight gain," Dr. Weisler said in a presentation on May 5.

In the 6-week trial, clinically important shifts in fasting glucose levels of 126 mg/dL or greater were seen in 0%, 3.4%, and 3.5% among patients taking quetiapine ER at a dose of 50, 150, or 300 mg, respectively, versus 1.6% in the placebo arm.

However, in long-term clinical trials in which patients took quetiapine for a mean of 213 days, hyperglycemia was observed in 10.7% of patients, Dr. Weisler noted.

Funding for this research was provided by AstraZeneca.

[Presentation title: Extended Release Quetiapine Fumarate (XR) Monotherapy for Major Depressive Disorder (MDD): A Double-Blind, Placebo Controlled Study. NR3-101]

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