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Quetiapine Extended-Release May Be Effective for Generalized Anxiety Disorder: Presented at APA

By Charlene Laino

WASHINGTON, DC -- May 9, 2008 -- Extended-release (ER) quetiapine monotherapy may help decrease symptoms of anxiety in patients with generalized anxiety disorder as early as 7 days after treatment begins, according to results of a randomized, double-blind, placebo-controlled study.

Martin Katzman, MD, Assistant Professor, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada, presented the findings here on May 5 at the 161st Annual Meeting of the American Psychiatric Association (APA).

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

Researchers who conducted a previous study of quetiapine ER for the treatment of other disorders found that patients' anxiety levels frequently decreased, Dr. Katzman said.

The observation led to the current study, in which 951 patients were randomized to receive quetiapine ER at 1 of 3 doses -- 50, 150, or 300 mg -- or placebo, once daily for 8 weeks, followed by a 2-week drug-discontinuation/tapering phase.

There were 234 patients in the 50-mg/day arm, 241 patients in the 150-mg/day arm, 241 patients in the 300-mg/day arm, and 235 patients in the placebo arm.

The researchers used the Hamilton Rating Scale for Anxiety (HAM-A) as the primary assessment of anxiety symptoms. The overall mean baseline score on the HAM-A scale was 24.6 in all arms. The primary endpoint was the change in the HAM-A total score from baseline to week 8.

At week 8, the mean HAM-A score was significantly reduced versus placebo in the 50- and 150-mg arms, but not in the 300-mg arm.

The score decreased by 11.1 points in the placebo arm, compared with 13.3 points in the 50- mg arm (P < .001), 13.5 points in the 150-mg arm (P < .001), and 11.7 points in the 300-mg arm (P = .24).

Anxiety scores decreased significantly in all 3 quetiapine arms at week 1 compared with placebo, Dr. Katzman reported.

While treatment for generalized anxiety typically includes an antidepressant, approximately 30% of patients do not achieve an adequate response to short-term treatment, he noted.

"With quetiapine extended-release, anxiety symptoms begin to improve as early as week 1, and [with the 50-mg and 150-mg doses], that improvement continued over the course of the 8 week trial," Dr. Katzman said.

The most common adverse events associated with the use of quetiapine ER versus placebo included dry mouth, sedation, somnolence, and dizziness.

Funding for this research was provided by AstraZeneca.

[Presentation title: Efficacy and Safety of Extended Release Quetiapine Fumarate (Quetiapine XR) Monotherapy in Patients With Generalized Anxiety Disorder (GAD). Abstract NR3-138]

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